Investigation ¿ evaluation: investigation methods used include a review of complaint history, the device history record, specifications, and a visual inspection of the returned device.One unopened bander ureteral diversion stent set package was returned for investigation.A visual examination of the returned package confirmed a black o-ring loose inside the packaging tray within the sealed package.All three fittings in the set were disassembled confirming o rings present in each connector.Based on the evidence presented by the sample, this event has been contributed to a packaging error.A review of the device history record was performed.A non-conformance was identified for a component missing.The description indicates that the component missing was a black o-ring.This missing o-ring appears to be what was in the returned complaint product.A review of complaint history for this device/lot combination revealed there have been no other complaints for this issue received against lot number 8545718.Based on the information provided and results of the investigation, the cause of this issue is manufacturing related.The relevant personnel in manufacturing were informed of this complaint.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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