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

Catalog Number	33416
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter tube had already been placed in the patient but only worked for about an hour.They mention that this balloon only inflated to 18ml, and it broke.Fortunately, it did not cause any harm to the patient.
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: 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.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned single sample (one photo) identified one silastic foley catheter that was opened and returned with its original packaging.Visual inspection of the photo showed the catheter with a ruptured balloon.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab f and 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.
Event or Problem Description
It was reported that the foley catheter tube had already been placed in the patient but only worked for about an hour.They mention that this balloon only inflated to 18ml, and it broke.Fortunately, it did not cause any harm to the patient.Per potential follow up information received via ibc on 29aug2025, stated that there was no medical intervention needed.Per follow up information received via rcc on 29aug2025, stated that there was discomfort because it was already in place and had to be removed.

• Brand Name: BARD® SILASTIC® 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: 22905089
• Report Number: 1018233-2025-07164
• Device Sequence Number: 8851666
• Product Code: EZL
• UDI-Device Identifier: 00801741019982
• UDI-Public: (01)00801741019982(11)241026(17)270331(10)NGJX3061
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 33416
• Device Lot Number: NGJX3061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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