BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

    MDR report key: 8876786 · Received August 8, 2019

    Report

    Report Number
    1018233-2019-04591
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741069789
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS INCONCLUSIVE SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE IDENTIFIED WAS OPERATOR ERROR - VISCOMETER OOC - VISCOMETER FAILURE - MECHANICAL FAILURE." THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INTENDED USE: THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. PLEASE CONTACT YOUR PHYSICIAN TO DETERMINE WHICH PRODUCT OPTIONS ARE BEST FOR YOU, PAYING CLOSE ATTENTION TO PRODUCT WARNINGS/ PRECAUTIONS AND ADVERSE REACTIONS. WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. RELEASE THE STERILE WATER FROM THE FOIL PACKET. TIP THE CATHETER POUCH END-TO-END THREE TO SIX TIMES SO THE WATER MOVES BACK AND FORTH TO THOROUGHLY WET THE CATHETER SURFACE. PEEL OPEN THE PACK AT THE FUNNEL END JUST ENOUGH TO EXPOSE THE INSERTION SLEEVE. DON¿T REMOVE THE CATHETER YET. USE THE ADHESIVE TAB AT THE FUNNEL END OF THE PACK TO STICK THE PACK TO A NEARBY VERTICAL SURFACE WHILE PREPARING TO CATHETERIZE. WASH THE AREA AROUND THE MEATUS BEFORE CATHETERIZING. WASH YOUR HANDS AGAIN. HOLD THE INSERTION SLEEVE WITH YOUR DOMINANT HAND AND SQUEEZE IT TO GRIP THE CATHETER SHAFT AS YOU REMOVE THE CATHETER FROM THE PACK. NEXT, HOLD THE CATHETER FUNNEL ABOVE THE INSERTION SLEEVE WITH YOUR OTHER HAND AND SLIDE THE INSERTION SLEEVE DOWN THE SHAFT, STOPPING AT ABOUT 6¿ FROM THE TIP. RELEASE THE FUNNEL. USING THE INSERTION SLEEVE TO HOLD THE CATHETER FIRMLY, GENTLY PASS THE TIP OF THE CATHETER INTO YOUR URETHRA UNTIL THE INSERTION SLEEVE NEARS THE MEATUS. REPEAT UNTIL URINE STARTS TO FLOW. TRY TO KEEP THE CATHETER STEADY UNTIL URINE STOPS FLOWING. WHEN URINE STOPS FLOWING, SLOWLY WITHDRAW THE CATHETER, STOPPING IF FLOW STARTS AGAIN, UNTIL THE LAST FEW DROPS HAVE DRAINED. FINISH BY DISPOSING OF THE CATHETER AND ITS PACKAGING. WASH YOUR HANDS WITH SOAP AND WATER. WARNING: THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE. MADE OF SILICONE ELASTOMER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX OF MAGIC 3 CATHETERS IS DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670538 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE MAGIC 3 CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 53616G UNK 00801741069789

    Patients

    Seq Age Sex Outcome Treatment
    1