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

Catalog Number	0165SI12
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use when water was injected, a hole opened in the vicinity of the balloon and water leaked out.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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
It was reported that before use when water was injected, a hole opened in the vicinity of the balloon and water leaked out.
Additional Manufacturer Narrative
The reported event was confirmed ¿ 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.The labeling and instructions for use were found to be adequate.A review of the manufacturing process indicates that the process is capable of producing of this type of defect.However, current in-process controls per pfmea are adequate to identify the defect or verify the product integrity.Corrections: d, h.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® I.C. 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: 23327548
• Report Number: 1018233-2025-09287
• Device Sequence Number: 21476069
• Product Code: MJC
• UDI-Device Identifier: 00801741016738
• UDI-Public: (01)00801741016738(11)250117(17)270628(10)MYJX3612
• Combination Product (Y/N): Y
• 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): 01/22/2026

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: 0165SI12
• Device Lot Number: MYJX3612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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