MalfunctionMJC

LUBRI-SIL® I.C. COMPLETE CARE® TEMP-SENSING FOLEY CATHETER TRAY AND URINE METER

Received Jun 26, 2026 · Event occurred Jun 17, 2026

Report 25634463 · MDR key 25634463

Device

Generic name

Catheter, Urological (antimicrobial) And Accessories

Manufacturer

C. R. Bard, Inc.

Lot number

NGLQ4418

Patient

54 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

UPON REMOVAL OF THE FOLEY CATHETER, A SLIT IN THE BALLOON WAS NOTED. BECAUSE OF THIS, A CYSTOSCOPY WAS PERFORMED. THERE WAS NO EVIDENCE OF INJURY OR FOREIGN BODY, AND STRONG BILATERAL JETS WERE NOTED FROM THE URETERAL ORIFICES.