BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ INTERMITTENT CATHETER

    MDR report key: 9104991 · Received September 23, 2019

    Report

    Report Number
    1018233-2019-05849
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Report Date
    October 4, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741068423
    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 WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿TOO HIGH/TOO LOW TEMPERATURE¿. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "THERMOCOUPLE OOC". 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: "FOR UROLOGICAL USE ONLY. URINARY CATHETERS ARE INTENDED FOR USE FOR BLADDER MANAGEMENT INCLUDING URINE DRAINAGE, COLLECTION AND MEASUREMENT. THE DEVICES ARE PASSED TO THE URINARY BLADDER VIA THE URETHRA. WARNINGS: THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. HOW TO PREPARE AND USE YOUR URINARY CATHETER 1. WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. 2. PEEL OPEN THE PACK AT THE FUNNEL END TO EXPOSE APPROXIMATELY 2¿- 4¿ OF THE CATHETER. DON¿T REMOVE THE CATHETER YET. 3. WASH THE AREA AROUND THE MEATUS BEFORE CATHETERIZING. 4. WASH YOUR HANDS AGAIN. 5. USING THE CATHETER: WITH SURE-GRIP¿ SLEEVE: A. HOLD THE SURE-GRIP¿ SLEEVE WITH YOUR DOMINANT HAND AND SQUEEZE IT TO HOLD THE CATHETER SHAFT AS YOU REMOVE THE CATHETER FROM THE PACK. B. NEXT, HOLD THE CATHETER FUNNEL ABOVE THE SURE-GRIP¿ SLEEVE WITH YOUR OTHER HAND AND SLIDE THE SURE-GRIP¿ SLEEVE DOWN THE SHAFT, STOPPING AT ABOUT 6¿ FROM THE TIP. RELEASE THE FUNNEL. C. USING THE SURE-GRIP¿ SLEEVE TO HOLD THE CATHETER FIRMLY, LUBRICATE CATHETER TIP WITH LUBRICATING GEL. D. WHILE GRIPPING THE CATHETER WITH THE SURE-GRIP¿ SLEEVE, GENTLY PASS THE TIP OF THE CATHETER INTO YOUR URETHRA UNTIL THE SURE-GRIP¿ SLEEVE NEARS THE MEATUS. IF THERE IS NO URINE FLOW, LOOSEN THE TENSION ON THE SURE-GRIP¿ SLEEVE TO ALLOW IT TO SLIDE BACK TOWARDS THE FUNNEL END. RE-GRIP SURE-GRIP¿ SLEEVE AND CONTINUE TO INSERT THE CATHETER INTO THE URETHRA. REPEAT UNTIL URINE STARTS TO FLOW. WITHOUT SURE-GRIP¿ SLEEVE: A. REMOVE THE CATHETER FROM THE PACK. B. LUBRICATE THE CATHETER TIP WITH LUBRICATING GEL. C. GENTLY PASS THE TIP OF THE CATHETER INTO YOUR URETHRA AND ADVANCE THE CATHETER UNTIL URINE STARTS TO FLOW. 6. 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. 7. FINISH BY DISPOSING OF THE CATHETER AND ITS PACKAGING. 8. WASH YOUR HANDS WITH SOAP AND WATER." 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 CATHETERS WERE MISSING EYELETS. NO MEDICAL INTERVENTION WAS REQUIRED.

    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 CATHETERS WERE MISSING EYELETS. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901562 MAGIC3¿ INTERMITTENT CATHETER MAGIC 3 CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 53314 JUCY0426 00801741068423

    Patients

    Seq Age Sex Outcome Treatment
    1