H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4: (expiry date: 05/2024).H11: 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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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 19cm equistream d/l catheter, one 15.0fr peel-apart sheath and vessel dilator, one 8fr & 12fr dilator, one introducer needle, one end cap, one j-tip guidewire in a guidewire hoop, one tunneler with a loaded protective sheath and two used adhesive dressings were returned for evaluation.Gross visual, tactile and functional testing were performed.A stylet was loaded to the red luer and a kink was noted on the stylet, proximal to the hub.No leaks were observed throughout the catheter.Therefore, the investigation is confirmed for the reported deformation issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 05/2024), g3, h6 (method) h11: h6 (result, conclusion) h11: 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.H3 other text : see h10.
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