MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX SILICONE COATED FOLEY CATHETER; FOLEY CATHETER (SILICONE COATED)

Model Number	0165V16S
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/09/2020
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 two catheters were clogged.The first one was in early november and second one was on (b)(6) 2020.Per customer via phone on (b)(6) 2020, the customer stated that the catheter was in place for about 3 days, when the patient started feeling the pain and some pressure.The customer noticed the catheter was clogged and badly drained which caused the pain and pressure.No medical intervention was required, however, the patient had to keep the catheter irrigated to get it drain.
Event or Problem Description
It was reported that the two catheters were clogged.The first one was in early november and second one was on 15nov2020.Per customer via phone on (b)(6) 2020 the customer stated that the catheter was in place for about 3 days when the patient started feeling the pain and some pressure.The customer noticed the catheter was clogged and badly drained which caused the pain and pressure.No medical intervention was required however the patient had to keep the catheter irrigated to get it drain.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to biological deposits or lumen collapse or foreign matter in lumen or blocked by clots.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.1) use luer tip syringe to inflate with stated ml of sterile water.2) for prefilled products remove clip and squeeze reservoir to inflate with stated ml of sterile water.Should balloon rupture occur care should be taken to assure all balloon fragments have been removed from the patient." the device was not returned.

• Brand Name: BARDEX SILICONE COATED FOLEY CATHETER
• Common Device Name: FOLEY CATHETER (SILICONE COATED)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10991828
• Report Number: 1018233-2020-21587
• Device Sequence Number: 11649876
• Product Code: EZC
• UDI-Device Identifier: 00801741039393
• UDI-Public: (01)00801741039393
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: 0165V16S
• Device Catalogue Number: 0165V16S
• Device Lot Number: NGEQ2945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other