MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER

Catalog Number	165822
Medical Device Problem Codes	Nonstandard Device (1420); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer is seeking full credit on an order of foley catheters due to manufacturing defects.They have only recently discovered.Due to the nature of catheter packaging, it is impossible to inspect the catheters upon receipt to identify such defects while maintaining their sterility.On order (b)(4) from (b)(6) 2024, the customer received two cases of bardex foley catheter, part 165822, from what appears to be a defective lot.Roughly 7 of the 12 catheters had either surface defects (burrs) or had loose flaps of silicone stuck to them.Five of these catheters caused minor internal trauma or irritation, in three cases producing blood upon removal.They did not use the last two catheters from this case, and instead they opened them up and found one with a loose flap of silicone.The defective lot is ngjv0914.The customer has one remaining case of 12 catheters from this lot.The customer cannot use it due to the substantial manufacturing defects in its sibling case.The patient wishes to return this case to you for full credit and so you can forward it to bard for any investigation they care to perform.Defects in catheters are important enough that the fda tracks them.The customer would appreciate the company conducting the necessary follow-through on this request, both with me and with bard.Please inform me as to the disposition of the defective case of catheters currently in the customer's possession.Of the four cases of bardex (b)(4) in the order: 1) the first case i used was from a different lot, and there was only one bad catheter in it.The customer used the rest of the case successfully.2) the second case is the lot with numerous defective pieces, and which i sent you photos from.There are no catheters left from this one.3) a third case, unused, is from the same lot as the second case.This is the case the customer is writing you about.4) a fourth case, unused, is from a different lot (ngjt1604).I haven't started it yet.If you're going to talk to bard, it would make me feel better if you could please ask whether there have been problems with this lot as well--and if so, we should arrange a return of this case too.
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: sections 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.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• 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, GA 30014 ; 7707846100
• MDR Report Key: 23426682
• Report Number: 1018233-2025-09744
• Device Sequence Number: 8242699
• Product Code: EZL
• UDI-Device Identifier: 00801741029783
• UDI-Public: (01)00801741029783(11)250831(17)281130(10)NGJV0914
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 165822
• Device Lot Number: NGJV0914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2024
• 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