MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE

Catalog Number	0102L16
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The urology patient with a standing prescription for monthly foley catheters, which they insert themselves with permission of their doctor and had been using the bard item 0102l16 for about three years and get them from norco medical supply company.Three of the catheters had been defective, two with a slow leak at the funnel end.The customer used them with the bard flip-flo valve (bff20), also thought it might be the valve that was the problem, but when replaced the valve, the leak continued.The customer determined that it was not from the end of the valve but from the funnel end of the catheter where it fitted over the valve stem and thought it must have been a one-in-a-million defect, but then it happened again with another catheter.When the replaced that one and kept it to examine the funnel end and saw that there was a vertical slit in the whitish lining material that allowed the leakage.It was miserable having to contend with seepage for a month (medicare only allows one catheter per month).There was obviously something wrong with the manufacturing and quality-control processes at bard.The customer requested the customer look into this and that the replace the two defective items and received.Also received one catheter with no bump on the funnel end to indicate the proper orientation for insertion of a coude tip.The customer called norco about that one, and they sent a replacement.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - 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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A labeling review was not performed because labeling could not have prevented the reported failure.The dhr review could not be performed without a lot number.Udi format updated with available product information per gudid.H11: section a through f - 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.
Event or Problem Description
The urology patient with a standing prescription for monthly foley catheters, which they insert themself with permission of their doctor and had been using the bard item 0102l16 for about three years and get them from norco medical supply company.Three of the catheters had been defective, two with a slow leak at the funnel end.The customer used them with the bard flip-flo valve (bff20), also thought it might be the valve that was the problem, but when replaced the valve, the leak continued.The customer determined that it was not from the end of the valve but from the funnel end of the catheter where it fitted over the valve stem and thought it must have been a one-in-a-million defect, but then it happened again with another catheter.When the replaced that one and kept it to examine the funnel end and saw that there was a vertical slit in the whitish lining material that allowed the leakage.It was miserable having to contend with seepage for a month (medicare only allows one catheter per month).There was obviously something wrong with the manufacturing and quality-control processes at bard.The customer requested the customer look into this and that the replace the two defective items and received.Also received one catheter with no bump on the funnel end to indicate the proper orientation for insertion of a coude tip.The customer called norco about that one, and they sent a replacement.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21384108
• Report Number: 1018233-2025-00900
• Device Sequence Number: 20981157
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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 Catalogue Number: 0102L16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown