The following were reviewed as part of this investigation: sample (if available), patient severity, applicable previous investigation(s), complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a poor connection in a groshong nxt connector is confirmed and was determined to be manufacturing related.Four 4 fr two-piece groshong nxt connectors and one stiffening stylet with flushing hub attached were returned for evaluation.An initial visual observation showed some use residue on the returned samples.The connectors were returned not assembled, and the blue internal compression sleeve of each distal connector piece appears to have been advanced.A microscopic observation revealed the locking arms of the proximal connector pieces were very slightly damaged.An attempt was made to assemble and then disassemble the connectors.An audible click could be heard when each connector was assembled; however, each connector was found to be able to be pulled apart by hand with some force.The distance between the locking arms of the proximal connector pieces was measured and each was found to be too wide and out of specification.The manufacturing facility was notified of this event, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A batch history review (bhr) of refx2635 showed four other similar product complaint(s) from this lot number.
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It was reported that the extension tubing had a problem, unable to be engaged.Since there was no spare part available, the catheter was scrapped.No other information was provided.02/17/2023 - the returned samples exhibited damage on the locking arms of the proximal connector.It was reported this occurred with four devices.This report addresses the second device.
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