BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA FOLEY CATHETER SILICONE COATED K922431

    MDR report key: 12729363 · Received November 1, 2021

    Report

    Report Number
    1018233-2021-06841
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    June 5, 2021
    Report Date
    October 12, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    PMA / PMN Number
    K922431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE USER RELATED (EXAMPLE: OVER ASPIRATED, INCORRECT SYRINGE/COLLAPSE LUMEN/SAC CLOSE EYE/VALVE DAMAGE). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE NO ADDITIONAL ACTION REQUIRED AT THIS TIME. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "SCOPE OF APPLICATION: FOLEY CATHETER IS INTENDED FOR USE IN THE DRAINAGE OF URINE FROM THE BLADDER OF CHILDREN AND ADULTS. PRECAUTIONS: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION. STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGED. WARNING: DO NOT USE PETROLEUM SUBSTRATE LUBRICANTS WITH THE LATEX-BASED URETHRAL CATHETERS, SUCH AS PETROLEUM JELLY AND LABEL LIQUID PARAFFIN, WHICH WILL DAMAGE LATEX AND MAY BURST BALLOON. WATER-SOLUBLE LUBRICANT CAN BE USED. DO NOT ASPIRATE URINE THROUGH THE DRAINAGE FUNNEL WALL. SINGLE USE ONLY. DO NOT RE-STERILIZE. FOR UROLOGICAL USE ONLY. PLEASE INSPECT VISUALLY FOR COMPLETENESS OR SURFACE WEAR OF THE PRODUCT BEFORE IT IS USED. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A SYRINGE IN THE CATHETER VALVE. NEVER USE EXCESSIVE FORCE TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN. IF PERMITTED BY HOSPITAL PRACTICAL, THE VALVE MAY BE CUT OFF. IF THIS FAILS, PLEASE CONTACT AN ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PRACTICAL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT". THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT ARTIFICIAL HIP REPLACEMENT WAS SCHEDULED TO BE PERFORMED IN THE MORNING OF (B)(6) 2021. THEREFORE, PREOPERATIVE INDWELLING CATHETERIZATION WAS PERFORMED AT 6:50 AM ON (B)(6) 2021 AS INSTRUCTED BY THE DOCTOR, AND THE OPERATION WAS SUSPENDED ON THE SAME DAY DUE TO INCOMPLETE PREPARATION OF SURGICAL EQUIPMENT. ON THE SAME DAY, THE NURSE COULD NOT EXTRACT THE NORMAL SALINE IN THE CATHETER BALLOON BY VARIOUS METHODS, AND THE BALLOON REMAINED INFLATED, SO THE CATHETER COULD NOT BE EXTUBATED. THE AGENT SALESMAN INFORMED SEVERAL EMERGENCY MEASURES, ONE WAS TO USE THE GUIDE WIRE OF UROLOGY TOOLS FOR PUNCTURE, THE OTHER WAS TO USE SURGERY. LATER, THE CLINICAL DEPARTMENT FIRST INDWELLED THE URETER, AND CALLED THE URETER CATHETER TO THE OPERATING ROOM OF THE OTHER HOSPITAL. AFTER THE OPERATION OF LEFT ARTIFICIAL HIP REPLACEMENT AT ON (B)(6), THE INTRAOPERATIVE DOCTOR PUNCTURED THE BALLOON WITH THE GUIDE WIRE, PULLED OUT THE CATHETER, AND THE BALLOON WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630669 BARDIA FOLEY CATHETER SILICONE COATED K922431 SILICONE FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 MYDS7042

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention