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

Catalog Number	0165SI18
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 10ml of fixed water was injected.Pale blood was discharged from urine.The patient did not like the catheter being fixed, so rehabilitation pants were put on without fixing it.The patient was informed that the catheter had came out when straining to defecate and the catheter was handed back with the fixed water still inflated.Upon closer inspection, one side of the foley catheter was bulging, and it was pointed out that that may had been the cause.No medical intervention was required.
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 that 10ml of fixed water was injected.Pale blood was discharged from urine.The patient did not like the catheter being fixed, so rehabilitation pants were put on without fixing it.The patient was informed that the catheter had came out when straining to defecate and the catheter was handed back with the fixed water still inflated.Upon closer inspection, one side of the foley catheter was bulging, and it was pointed out that that may had been the cause.No medical intervention was required.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The returned device was functionally tested, and the product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.Pfmea ra87p017 rev 12 (overnight leaching of foley catheters) was reviewed for this investigation.The failure mode is addressed in step/item #4.A potential root cause for this failure mode could be allergic reaction in patient.Based on information in the fmea, the risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.A review of the device labeling has been conducted for investigation purposed.The ifu is attached on the investigation overview element.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Correction: d, e, 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.

• Brand Name: BARDEX® I.C. 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: 22212803
• Report Number: 1018233-2025-04636
• Device Sequence Number: 8659787
• Product Code: MJC
• UDI-Device Identifier: 00801741016769
• UDI-Public: (01)00801741016769(11)200821(17)250528(10)MYEU2762
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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
• Device Expiration Date: 05/28/2025
• Device Catalogue Number: 0165SI18
• Device Lot Number: MYEU2762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• 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