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

Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Skin Tears (2516); Hematuria (2558); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
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.Initial reporter name: (b)(6).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 "when we take an indwelling urinary catheter (iuc) out and the patient was still retaining, we are having issues with our 14fr i/o causing urethral irritation, micro-tearing, slightly pink tinged urine from trauma, and patient complaints of friction/pain.Due to this we are having to replace iucs instead of doing i/o on the patient more than 1-2 times due to patient and or team member complaints." no medical intervention was reported.
Event or Problem Description
It was reported that when we take an indwelling urinary catheter (iuc) out and the patient was still retaining, they were having issues with the 14fr i/o causing urethral irritation, micro-tearing, slightly pink tinged urine from trauma, and patient complaints of friction/pain.Due to this they needed to replace iucs instead of doing i/o on the patient more than 1-2 times due to patient and or team member complaints.No medical intervention was reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, d, e, f, g, h the reported product number is unknown.The udi number for this product is not available.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 "when we take an indwelling urinary catheter (iuc) out and the patient was still retaining, we are having issues with our 14fr i/o causing urethral irritation, micro-tearing, slightly pink tinged urine from trauma, and patient complaints of friction/pain.Due to this we are having to replace iucs instead of doing i/o on the patient more than 1-2 times due to patient and or team member complaints." no medical intervention was reported.
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.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.The dhr review could not be performed without a lot number.Therefore, no additional action required at this time.The reported product number is unknown.The udi number for this product is not available.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: UNKNOWN LATEX 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: 23038004
• Report Number: 1018233-2025-08006
• Device Sequence Number: 13297596
• Product Code: EZC
• UDI-Device Identifier: 00801741068423
• UDI-Public: (01)00801741068423
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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): 11/04/2025

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
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 11/04/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 09/30/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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