It was reported that six months and five days post a dialysis catheter placement, the catheter was allegedly broken at the hub part.It was further reported that the catheter allegedly had a leak.Reportedly, the catheter was replaced.There was no reported patient injury.
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As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 03/2024) 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.
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