Manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one powerport mri isp, one groshong catheter with pre-inserted stylet, one flushing connector, one introducer needle, one straight non-coring needle, two catheter locks, one syringe, one guidewire in a guidewire hoop, one introducer peel-apart sheath and vessel dilator, one safety infusion set, and one tunneler were returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the identified fracture problem as multiple cracks were noted on the introducer needle hub.Aspiration difficulty was noted upon aspirating the needle during functional evaluation.No leaks were noted from the needle hub, although the device did not fully aspirate and it appeared that the in-house syringe was aspirating water as well as air.However, the investigation is inconclusive for the reported aspiration difficulty and air leak issue as the exact circumstances at the time of the reported event are unknown and the sample evaluation results indicating difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Expiry date: 04/2023.Section a through f - the information provided by bd represents all of 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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