MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® I.C. Foley Catheter

Catalog Number	0165SI14
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during placement during surgery when urine volume was checked during surgery, there was almost no urine accumulated.The foley catheter had spontaneously dislodged, and the leak location was unknown.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.The reported failure was able to be reproduced.The product was used for urological care.Based on the evaluation, a tear was found on the rubberized layer causing interlumen leakage.Hence, this complaint was confirmed related to manufacturing process.A potential root cause for this failure could be insufficient latex strength, low/non-uniform rubberize thickness, incorrect wire pressing technique, incorrect stripping technique etc.No deviations or nonconformances related to the reported issue were identified.The labeling / packaging record review did not identify any labeling / packaging related conditions associated with the reported failure mode.Manufacturing process indicates that the process is capable of producing of this type of defect.However, a review of the device history record did not show any problems or condition that would have contributed to the reported issue.Current in process controls per pfmea are adequate to identify the defect or verify the product integrity.Therefore, no additional action required at this time.Corrections: 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 ; +1(770)784-6100
• MDR Report Key: 50209941
• Report Number: 1018233-2026-05306
• Device Sequence Number: 15952102
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745(17)270728(10)MYLQ2826
• Combination Product (Y/N): Y
• Initial Reporter State: NA
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2026

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: 0165SI14
• Device Lot Number: MYLQ2826
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 09/27/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2026
• 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