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din engleză în română: Field Safety Notice General field: Tehnică/Inginerie Detailed field: Medical: Instrumente
Text sursă - engleză Issue
As part of W®’s quality process, a packaging discrepancy was identified in specific lots of W®’s X® packaging. It was found that the outer blister container did not meet W®’s internal packaging specifications: specifically, seal width and/or breach of the outer seal. Each potentially affected X® packaging unit includes an inner and outer blister container. The inner blister was found intact, and product sterility was not compromised.
Potential Hazards
The potential hazards manifest in the following possible sequence of events where the outer blister container displays an inconsistent or breached seal.
• Unusual seal is recognized by OR nurse and the device is not utilized, resulting in a delay in surgery of less than 5 minutes while a new device of same size is obtained or, where a same size device is not available, a different size device is utilized to complete the procedure.
• Unusual seal is not recognized by OR nurse and the device is utilized, potentially allowing the ingress of contaminates into the space between the inner and outer blister if there is damage to the shrink-wrap and/or carton and outer blister seal. This can potentially result in introduction of contaminates into the sterile surgical field. Please note that this is a hypothetical scenario as W® has not received any reports of such events occurring.
Based on a Medical Assessment of this matter, extensive testing of affected devices which demonstrates no contamination of the space between the inner and outer blister and the existence of multiple contaminate barriers within a packaging unit which meet packaging specifications, including the inner blister which functions as the primary sterility barrier, there is no increased health risk to patients implanted with product associated with affected X® packaging.
Traducere - română Problema
Ca parte a procesului de verificare a calităţii efectuat de W®, a fost identificată o discrepanţă în anumite loturi ale ambalajelor X® distribuite de W®. S-a descoperit faptul că ambalajul blisterului extern nu respectă specificaţiile interne ale W® privind ambalarea: anume, lăţimea sigiliului şi/sau ruperea sigiliului extern. Fiecare unitate de ambalare X® posibil afectată include un ambalaj al blisterului intern şi extern. Blisterul intern a fost găsit intact iar sterilitatea produsului nu a fost compromisă.
Riscuri potenţiale
Riscurile potenţiale se manifestă în următoarea succesiune posibilă de evenimente, atunci când ambalajul blisterului extern prezintă un sigiliu necorespunzător sau rupt.
• Sigiliul neobişnuit este recunoscut de către asistenta din sala de operaţie iar dispozitivul nu este utilizat, ceea ce duce la o întârziere a operaţiei de sub 5 minute, timp în care este adus un dispozitiv nou, identic cu primul, sau în cazul în care un dispozitiv identic nu este disponibil, pentru a finaliza procedura se va utiliza un dispozitiv cu dimensiuni diferite.
• Sigiliul neobişnuit nu este recunoscut de către asistenta din sala de operaţie iar dispozitivul este utilizat, existând astfel riscul pătrunderii de contaminanţi în spaţiul dintre blisterul intern şi cel extern, în cazul în care există o deteriorare a foliei termocontractabile şi/sau a ambalajului din carton şi a sigiliului blisterului extern. Această situaţie poate avea ca posibil rezultat introducerea de contaminanţi în mediul chirurgical steril. Vă rugăm să reţineţi faptul că acesta este un scenariu ipotetic, deoarece W® nu a primit niciun raport care să semnaleze existenţa unor astfel de evenimente.
Pe baza unei evaluări medicale a acestei chestiuni, a testării ample a dispozitivelor afectate care demonstrează inexistenţa contaminării spaţiului dintre blisterul intern şi cel extern şi prezenţa unor multiple bariere împotriva contaminării în interiorul unei unităţi de ambalare, care respectă specificaţiile privind ambalarea, incluzând blisterul intern care funcţionează precum o barieră sterilă principală, nu s-a semnalat niciun risc crescut privind sănătatea la pacienţii cărora li s-a implantat un produs asociat cu un ambalaj X® afectat.
din engleză în română (State Authorization for English – Romanian, verified) din română în engleză (State Authorization for Romanian – English, verified)
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