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

Model Number	888806
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the complainant tried using the balloon dilation catheter in a case, but stated that it was defective.
Additional 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 or Problem 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
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10284823
• Report Number: 1018233-2020-04580
• Device Sequence Number: 2577302
• Product Code: EZN
• UDI-Device Identifier: 00801741053221
• UDI-Public: (01)00801741053221
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K993840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1