H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one quick connect hub, sterile sleeve and biopsy cannula were received for evaluation.During visual evaluation, it was noted that the biopsy stylet, needle grip, ejector rod, ejector guide and manual driver were not returned.On further observation, multiple perforations were noted to the sterile sleeve, stretching was noted to the sterile sleeve and the quick connect hub was x-rayed and it was noted that the distal uclip was found to be shifted slightly out of position.No other visual anomalies were noted to the device.Upon functional testing, resistance was felt when attaching and detaching the biopsy cannula from the quick connect hub/ sterile sleeve.No further functional testing was performed, due to the condition the sample was received.Therefore, the investigation is confirmed for the reported premature separation as distal uclip was found to be out of position, and this leads to the resistance observed while attaching and detaching the biopsy cannula from the quick connect hub.The investigation is also confirmed for identified material perforation as multiple perforation and stretching were noted on the sterile sleeve.However, the investigation is inconclusive for the reported difficult to remove as cause of the reported event cannot be replicated in the laboratory.A definitive root cause for the alleged premature separation issue is due to the distal-uclip which was found to be out of position.A definitive root cause for the reported difficult to remove and material perforation could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 02/2024).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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