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

Catalog Number	165814
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
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.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.
Event or Problem Description
It was reported that during use the foley catheter balloon deflated and it dislodged by itself without clinical intervention.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Received 1, 2-way all silicone foley catheter.Visual inspection noted the balloon was ruptured around all diameter.This does not meet specification which states "missing, damaged, leaking, torn, broken, incomplete or incorrect components are not permitted, the clamp must be closed." the potential root cause for this failure, per capa 12866756, is: 1.Silicone balloon molding pin configuration when removing the balloon from the mold.2.The inspection method is visual and relies on the operator¿s judgment to identify any leakage in the catheter balloon during the inflation.Risk review, labeling review, and dhr review are not required as event has already been investigated per capa 12866756.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.
Event or Problem Description
It was reported that during use the foley catheter balloon deflated and it dislodged by itself without clinical intervention.

• 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: 24602038
• Report Number: 1018233-2026-01761
• Device Sequence Number: 8384791
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745(11)251004(17)300630(10)NGKU1796
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

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: 165814
• Device Lot Number: NGKU1796
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 04/30/2026
• Initial Report FDA Received Date: 03/15/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2025
• 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