MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® Pediatric All-Silicone Foley Catheter

Catalog Number	165808
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the foley catheter inserted in cervix and inserted in uterus for case for chromotubation.At end of case foley was attempted to be removed.When balloon was attempted to be deflated, it would not deflate.Two different syringes were tried with no success.End port where syringe gets attached was cut by surgeon to attempt to manually deflate the balloon, and the balloon still did not deflate.Hysteroscopy was used to deflate balloon to remove from uterus/cervix.This was the second case of the day with the same ref: 165808 for this product where the balloon would not deflate.In both cases, the patient underwent hysteroscopy and used a needle to pop the balloon in order to remove the foley.There were 2 different lot numbers: ngkx1801 & ngkr2525.The surgeon has been performing this procedure for 19 years and is very experienced using the product and has only recently had this issue.
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.

• Brand Name: Bardex® Pediatric All-Silicone Foley Catheter
• Common Device Name: Silicone 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: 25340587
• Report Number: 1018233-2026-03501
• Device Sequence Number: 10002551
• Product Code: KOD
• UDI-Device Identifier: 00801741029714
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K821745
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 165808
• Device Lot Number: NGKR2525
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female