MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® I.C. Foley Catheter; Latex Foley Catheter

Catalog Number	0165SI14
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use after insertion of foley catheter, a hole opened up and the water used to secure it fell out.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.The product had caused the reported failure.Sample was evaluated and observed there was a pinhole on the bottom part of sac collar that allowed water to leak out.Pinhole was examined under microscope and noted to be round and smooth.A review of the manufacturing process indicates that the process can produce of this type of defect.Therefore, this failure mode confirmed manufacturing related.A potential root cause for this failure could be due to bubble during dipping process.No deviations or nonconformances related to the reported issue were identified.The labeling / packaging record review did not identify any labeling / packaging -related conditions associated with the reported failure mode.A review of the lot file showed no rejects or rework associated with this issue.For the affected date code, the rejected units were recorded as in process scrap and will be disposed of after inspection.No deviations or nonconformances related to the reported issue were identified.The dhr/bhr review did not identify any manufacturing related conditions associated with the reported failure mode.Corrections: d,e,h.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.

• Brand Name: Bardex® I.C. Foley Catheter
• Common Device Name: Latex 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 ; +1(770)784-6100
• MDR Report Key: 50214132
• Report Number: 1018233-2026-05328
• Device Sequence Number: 6110818
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (Y/N): Y
• Initial Reporter State: NA
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2026

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: 0165SI14
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2026
• Supplement Date Received by Manufacturer: 09/27/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2026
• 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