Investigation summary: no samples were received, therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.This is the 1st complaint for lot # 8100541 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
|
It was reported that the bd posiflush¿ normal saline syringe packaging was found damaged before use, compromising the sterile barrier.The following information was provided by the initial reporter, translated from (b)(6) to english: "before use, customer complaint 1ea flush package damaged.".
|