MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® Lubricath® Hematuria Foley Catheter

Catalog Number	2551HT20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the foley catheter was used after transurethral resection of the prostate (turp).The catheter with lot myjt3484 could not be removed after one week of placement because the patient was in pain.Computed tomography (ct) check revealed that the balloon had burst, and no sterile water was inside.Because the patient was in pain, it was removed under general anesthesia.There was contact stating that the patient was angry and they were struggling with how to handle the situation.There was also information that lindelone was applied as a substitute for jelly.Medical intervention required.Per additional information received on (b)(6) 2026, stated that during the patient¿s surgery, urethral dilation was performed due to severe pendulous urethral stricture.To prevent postoperative urethral restenosis and reduce local inflammation, lindelone vg ointment was applied at the conclusion of the surgery, and the product was inserted with the ointment applied to the external urethral orifice.Removal was performed under general anesthesia.A preoperative ct scan had already confirmed that the fixation fluid had been drained.Although removal during an outpatient visit was difficult due to the patient¿s severe pain, during the reoperation (removal under general anesthesia), the balloon could be removed simply by applying gradual traction.The rupture site of the balloon was only a tear with no loss of material; a cystoscope was used to examine the urethra and bladder, and no residual material was found.There was no urethral injury, so no additional invasive procedures were performed, and the procedure was concluded with reinsertion of the balloon.Per follow up notification received on 05jun2026, it was reported that the same issue which occurred for 2 separate lots, lot myjx4889 and lot myjx4890.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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® Lubricath® Hematuria 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: 25492203
• Report Number: 1018233-2026-03807
• Device Sequence Number: 21261678
• Product Code: KOD
• UDI-Device Identifier: 00801741025143
• UDI-Public: (01)00801741025143(11)241206(17)290828(10)MYJX4889
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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): 09/26/2026

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: 2551HT20
• Device Lot Number: MYJX4889
• Was Device Available for Evaluation?: No
• 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: 06/05/2026
• Supplement Date Received by Manufacturer: 09/26/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown