As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).
|
It was reported that sometime post dialysis catheter placement procedure, the catheter was allegedly bent.It was further reported that the catheter allegedly had a collapse during vacuuming the lumens.Reportedly, the device was removed and replaced.There was no reported patient injury.
|
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: the sample was not returned for evaluation.One electronic video was provided for review.The investigation is confirmed for the reported deformation issue as both the lumens of the catheter was found to be crimped just proximal to the bifurcation area.However the investigation is inconclusive for the reported collapse issue as the reported event cannot be confirmed from the provided video.The definitive root cause could not be determined based upon 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.H10: b5, d4 (expiry date: 02/2024).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.
|