BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3 COUDE INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE

    MDR report key: 11822435 · Received May 13, 2021

    Report

    Report Number
    1018233-2021-02769
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 21, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741068089
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO " OPERATOR ERROR". THE LOT NUMBER WAS 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." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAGIC 3 INTERMITTENT COUDE CATHETERS WERE USEABLE, BUT SOME WERE BENT AND OF POOR QUALITY. IT WAS ALSO STATED THAT THE CATHETERS WERE GENERALLY BAD FROM THE SAME LOTS. THE PATIENT STATED THAT THE ONES THAT WERE GOOD WERE GREAT, BUT THE ONES THAT WERE BAD WERE UNSATISFACTORY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAGIC 3 INTERMITTENT COUDE CATHETERS WERE USEABLE, BUT SOME WERE BENT AND OF POOR QUALITY. IT WAS ALSO STATED THAT THE CATHETERS WERE GENERALLY BAD FROM THE SAME LOTS. THE PATIENT STATED THAT THE ONES THAT WERE GOOD WERE GREAT, BUT THE ONES THAT WERE BAD WERE UNSATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716470 MAGIC3 COUDE INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE MAGIC3 COUDE INTERMITTENT CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 50614 UNK 00801741068089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other