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

Catalog Number	33418
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that two catheters received from the alberta aids to daily living pharmacy failed to drain as intended.As a result, the patient experienced bladder spasms and urine bypassing, which necessitated catheter replacement.The first catheter insertion occurred on monday morning, and a second catheter was inserted monday evening due to continued failure to drain.A third catheter insertion occurred on tuesday afternoon using home care stock, at which time more than 1,600 milliliters of urine drained within two hours.The product involved was a silastic foley catheter, 18 french, with a 30-cc ribbed balloon made of silastic material.
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.
Event or Problem Description
It was reported by the customer that two catheters received from the alberta aids to daily living pharmacy failed to drain as intended.As a result, the patient experienced bladder spasms and urine bypassing, which necessitated catheter replacement.The first catheter insertion occurred on monday morning, and a second catheter was inserted monday evening due to continued failure to drain.A third catheter insertion occurred on tuesday afternoon using home care stock, at which time more than 1,600 milliliters of urine drained within two hours.The product involved was a silastic foley catheter, 18 french, with a 30-cc ribbed balloon made of silastic material.
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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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: 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: 24861204
• Report Number: 1018233-2026-02432
• Device Sequence Number: 9367617
• Product Code: EZL
• UDI-Device Identifier: 00801741019999
• UDI-Public: (01)00801741019999(11)250816(17)290131(10)NGKT3436
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951103
• 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): 05/11/2026

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: 33418
• Device Lot Number: NGKT3436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 04/30/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2025
• 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