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	11/28/2025
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 reproted that the nurse placed a foley prior to their scheduled cesarean section per protocol.Nurse filled the foley bulb with 10ml and urine drained freely throughout case.Shortly after returning to the patient¿s room postoperatively, the foley fell out and the bulb was deflated.To troubleshoot, i filled the balloon again with 10ml of water.The balloon filled all the way, then slowly deflated over a couple minutes.The fluid was slowly leaking from the opening of the catheter tip, but the external balloon appeared intact.
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.The reported event is addressed within the labeling, and it states: ¿ visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.A device history record review could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: d.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 the nurse placed a foley prior to their scheduled cesarean section per protocol.Nurse filled the foley bulb with 10ml and urine drained freely throughout case.Shortly after returning to the patient¿s room postoperatively, the foley fell out and the bulb was deflated.To troubleshoot, i filled the balloon again with 10ml of water.The balloon filled all the way, then slowly deflated over a couple minutes.The fluid was slowly leaking from the opening of the catheter tip, but the external balloon appeared intact.
Event or Problem Description
It was reported that the nurse placed a foley prior to their scheduled cesarean section per protocol.Nurse filled the foley bulb with 10ml and urine drained freely throughout case.Shortly after returning to the patient¿s room postoperatively, the foley fell out and the bulb was deflated.To troubleshoot, i filled the balloon again with 10ml of water.The balloon filled all the way, then slowly deflated over a couple minutes.The fluid was slowly leaking from the opening of the catheter tip, but the external balloon appeared intact.
Additional Manufacturer Narrative
The reported event was confirmed capa 8266921 related.Visual evaluation of the returned sample noted one opened (without original packaging), used urine meter drainage bag with an inlet tube, sample port connector, catheter and test.Visual inspection of the sample noted that the catheter will be tested for "deflation due to trauma." using the (in house) syringe the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1 percent aq methylene blue per 100ml distilled water) and upon inflation ballon was able to inflate but solution leaked from eyelets.The balloon notch was dissected and a 0.025 pin gage fitted within perforation notch.A potential root cause for this failure could be "it was difficult to assure the positioning of the catheter due to vision was difficult".The labeling and risk assessment was not completed as they are addressed by existing capa 8266921.Dhr reviews are not required as the reported event is confirmed capa 8266921 related.Corrections: d, f, 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® 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: 23778294
• Report Number: 1018233-2025-11032
• Device Sequence Number: 15966927
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745(11)250829(17)300731(10)NGKV1050
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: NGKV1050
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/29/2026; 04/01/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/05/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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