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

Catalog Number	0167V22S
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was admitted for prostatic hyperplasia.On september 17 at 08:10, a transurethral partial prostatectomy combined with "great white shark" tissue morcellation was performed under combined spinal-epidural anesthesia.A three way urinary foley catheter was inserted intraoperatively.Upon returning to the ward at 11:00, bladder irrigation was initiated; however, significant resistance was encountered.Attempts to flush the catheter using a syringe filled with water met with similar resistance, indicating poor inflow.This situation posed a risk of urinary retention.Consequently, the catheter was removed and replaced with a new three way catheter from the same batch, resulting in unobstructed drainage.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.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: 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® Foley Catheter Silicone Coated
• 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; +1(770)784-6100
• MDR Report Key: 50895129
• Report Number: 1018233-2026-06099
• Device Sequence Number: 10712194
• Product Code: KOD
• UDI-Device Identifier: 00801741019234
• UDI-Public: (01)00801741019234(17)280428(10)MYHU0942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 0167V22S
• Device Lot Number: MYHU0942
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/25/2026
• 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