The reported event is confirmed, cause unknown.The ureteral stent with push catheter was returned in the original packaging.A tear, appearing to be caused by a sharp object was noted in the plastic sleeve covering the ureteral stent, this is out of specifications.As it is unknown when or how this tear occurred, this event will be confirmed, cause unknown.Though a specific cause cannot be determined, based on the risk document a potential root cause for this event could be, "sharps (external or internal)".As no patient involvement was reported, the device was not used, however is intended for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.Correction: d.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.H3 other text : the actual/suspected device was inspected.
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