BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMITTENT ROCHESTER CATHETERS

    MDR report key: 8740871 · Received June 27, 2019

    Report

    Report Number
    1018233-2019-03423
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Report Date
    July 18, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741069765
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE ¿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: "INSTRUCTIONS FOR USE 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 · 0

    IT WAS REPORTED THAT THE COATING ON THE CATHETER WAS TOO STICKY AFTER THE WATER PACKET WAS BURST.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COATING ON THE CATHETER WAS TOO STICKY AFTER THE WATER PACKET WAS BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535609 INTERMITTENT ROCHESTER CATHETERS MAGIC 3 CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 53612G UNK 00801741069765

    Patients

    Seq Age Sex Outcome Treatment
    1