MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UROFORCE BALLOON DILATION CATHETER

Model Number 888806

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the complainant tried using the balloon dilation catheter in a case, but stated that it was defective.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode was unable to determine due to a lack of information provided in the event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was unable to review due to a lack of information provided.

Event Description

It was reported that the complainant tried using the balloon dilation catheter in a case, but stated that it was defective.

• Brand Name: UROFORCE BALLOON DILATION CATHETER
• Type of Device: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10284823
• MDR Text Key: 199729285
• Report Number: 1018233-2020-04580
• Device Sequence Number: 1
• Product Code: EZN
• UDI-Device Identifier: 00801741053221
• UDI-Public: (01)00801741053221
• Combination Product (y/n): N
• PMA/PMN Number: K993840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 888806
• Device Catalogue Number: 888806
• Device Lot Number: GFEN2688
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1