BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

    MDR report key: 7611810 · Received June 18, 2018

    Report

    Report Number
    1018233-2018-02307
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Report Date
    October 5, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741069772
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. VISUAL EVALUATION NOTED 5 UNOPENED CATHETERS IN ORIGINAL PACKAGING. TWO OF THE WATER PACKETS WERE ABLE TO BE BURST WITH LITTLE FORCE APPLIED. LENGTH OF WATER PACKETS WAS MEASURED (74.25, 75.10, 73.98, 75.30, 76.80) AND WAS FOUND TO BE WITHIN SPECIFICATION (73.02-79.38MM). THE WIDTH OF THE WATER PACKETS WERE MEASURED (21.15, 20.95, 16.10, 18.80, 18.25) AND WERE FOUND TO BE WITHIN SPECIFICATION (15.87-22.23MM). THE VOLUME OF ALL THREE OF THE WATER SACHETS WERE MEASURED (3.7ML, 3.7ML, 3.8ML) AND WAS FOUND TO BE IN SPECIFICATION (3.7ML-4.3ML). THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WAS FOUND ADEQUATE AND STATES THE FOLLOWING: "INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE HYDROPHILIC COATED SILICONE 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." CORRECTION: MFR SITE, CONCOMITANT MEDICAL PRODUCTS AND DEVICE EVALUATED BY MFR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAGIC 3 CATHETER WATER PACKETS DID NOT HAVE ENOUGH WATER IN THEM, AND ALLEGEDLY THE CATHETERS WERE DRY. IT WAS NOTED THAT, THE PATIENT EXPERIENCED DISCOMFORT AND BLOOD IN HIS URINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT ALSO NOTED THAT THE HE WASHES HIS HANDS THOROUGHLY AND USES PURELL HAND SANITIZER BEFORE INSERTING EACH CATHETER HE USES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAGIC 3 CATHETER WATER PACKETS DID NOT HAVE ENOUGH WATER IN THEM, AND ALLEGEDLY THE CATHETERS WERE DRY. IT WAS NOTED THAT, THE PATIENT EXPERIENCED DISCOMFORT AND BLOOD IN HIS URINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT ALSO NOTED THAT THE HE WASHES HIS HANDS THOROUGHLY AND USES PURELL HAND SANITIZER BEFORE INSERTING EACH CATHETER HE USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450947 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE MAGIC 3 CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 53614G JUBX0567 00801741069772

    Patients

    Seq Age Sex Outcome Treatment
    1