BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT HYDROCOLLOID ADHESIVE SHEATH

    MDR report key: 11913937 · Received June 1, 2021

    Report

    Report Number
    1018233-2021-03156
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 6, 2021
    Report Date
    July 13, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741071348
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS INCONCLUSIVE. VISUAL EVALUATION NOTED 1 OPENED MEC WAS RECEIVED. VISUAL EVALUATION NOTED THE SAMPLE WAS USED AND THEREFORE NO TESTING COULD BE PERFORMED. THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED, A POTENTIAL ROOT CAUSE IS MECHANICAL FAILURE. 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: "INTENDED USE: THE SELF-ADHERING MALE EXTERNAL CATHETER IS USED FOR THE DRAINAGE OF URINE. THE CATHETER IS APPLIED BY THE PATIENT OR CAREGIVER. DESCRIPTION / INDICATION: THE SELF-ADHERING MALE EXTERNAL CATHETER IS DESIGNED FOR THE MANAGEMENT OF ADULT MALE URINARY INCONTINENCE. CONTRAINDICATION: DO NOT USE ON IRRITATED OR COMPROMISED SKIN. WARNING: REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY OR ILLNESS OF THE PATIENT. PRECAUTION: DO NOT USE IF ALLERGIC REACTION OCCURS OR IF PATIENT HAS KNOWN ALLERGIES TO DEVICE COMPONENTS. FOR GOOD HYGIENE, CHANGE CATHETER DAILY. USE OF A SINGLE DEVICE FOR LONGER PERIODS THAN 24 HOURS MAY INCREASE THE RISK OF COMPLICATIONS. FOLLOW DIRECTIONS TO REMOVE IF EXPERIENCING SWELLING, NUMBNESS, DISCOMFORT, PAIN, DISCOLORATION, OR ABNORMAL APPEARANCE. NOTE: IF EXPERIENCING PROBLEMS WITH USE OF THE DEVICE, PLEASE CONSULT YOUR HEALTHCARE PROFESSIONAL FOR ASSISTANCE. DIRECTIONS TO APPLY: 1) VERIFY CORRECT SIZE PRIOR TO USE. 2) TRIM PUBIC HAIR IF NECESSARY. 3) WASH PENIS WITH MILD SOAP AND WARM WATER. DRY THOROUGHLY. WEAR TIME MAY BE REDUCED IF SKIN IS NOT DRY OR CREAM/OIL IS USED. 4) OPEN PACKAGE AT PERFORATION. REMOVE CATHETER FROM PLASTIC INSERT, IF PRESENT. 5) PLACE ROLLED END OVER THE END OF THE PENIS, LEAVING A SMALL SPACE BETWEEN THE END OF THE PENIS AND THE CONE OF THE CATHETER. 6) UNROLL THE CATHETER OVER PENIS. 7) GENTLY SQUEEZE THE CATHETER TO PROPERLY SEAL ADHESIVE TO THE SKIN. IF POSSIBLE, AVOID LEAVING A ROLLED ¿COLLAR¿ AROUND THE BASE OF THE PENIS. IMPORTANT: WEAR TIME MAY BE REDUCED IF ADHESIVE IS NOT PROPERLY SEALED TO THE SKIN. 8) CONNECT THE CATHETER TO A DRAINAGE SYSTEM. MAKE SURE TO CHECK THAT CONNECTIONS ARE SECURE BEFORE USE. DIRECTIONS TO REMOVE: 1) ENSURE DRAINAGE BAG IS EMPTY. 2) DISCONNECT CATHETER FROM THE DRAINAGE SYSTEM. 3) GENTLY ROLL THE CATHETER FORWARD AND OFF THE PENIS. IF NECESSARY, APPLY A WARM WET COMPRESS (SUCH AS A WET WASHCLOTH) AROUND THE CATHETER TO HELP LOOSEN THE ADHESIVE. DISPOSAL: AFTER REMOVAL, DISPOSE BY PLACING THE USED CATHETER INTO A WASTE CONTAINER." 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. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT USING MALE EXTERNAL CATHETER HAD 3 OCCASIONS WHERE THE CATHETER HAD COME OFF AT NIGHT. PATIENT NOTICED THAT CATHETER DID NOT COME ALL THE WAY UP THE PENIS SHAFT AS THEY USED TO AND ALSO STATED THAT THE CATHETERS WERE USUALLY MORE DIFFICULT TO REMOVE. PATIENT WAS NOT SURE IF CATHETERS WERE COMING OFF BECAUSE THEY DID NOT HAVE ENOUGH ADHESIVE OR IF THEY WERE NOT LONG ENOUGH AND DID COMPLIMENT THAT THE SAFETY CAP THAT KEEPS THEM CLEAN. IT WAS ALSO REPORTED THAT THE MALE EXTERNAL CATHETERS HAD NOT GOOD ADHESIVE FOR LOT #JUEX2025 AND FOR LOT #JUEZ0288 AND THE CATHETERS WERE SHORTER THAN USUAL LOT#JUEZ0288. ALSO, CUSTOMER WANTED TO KNOW IF THERE HAD BEEN A CHANGE IN THE PRODUCT. PER CUSTOMER VIA PHONE ON 19MAY2021, CUSTOMER STATED THAT THE MALE EXTERNAL CATHETER WAS TOO BIG ( LOT # JUEY1009), HAD WEAK ADHESIVE (LOT # JUEY1009) THAT CAUSED ROLLED RIGHT OFF AND HALF WERE FOUND TO BE SHORTER (LOT # JUEY1009).

    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 PATIENT USING MALE EXTERNAL CATHETER HAD 3 OCCASIONS WHERE THE CATHETER HAD COME OFF AT NIGHT. PATIENT NOTICED THAT CATHETER DID NOT COME ALL THE WAY UP THE PENIS SHAFT AS THEY USED TO AND ALSO STATED THAT THE CATHETERS WERE USUALLY MORE DIFFICULT TO REMOVE. PATIENT WAS NOT SURE IF CATHETERS WERE COMING OFF BECAUSE THEY DID NOT HAVE ENOUGH ADHESIVE OR IF THEY WERE NOT LONG ENOUGH AND DID COMPLIMENT THAT THE SAFETY CAP THAT KEEPS THEM CLEAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810119 SPIRIT HYDROCOLLOID ADHESIVE SHEATH MALE EXTERNAL CATHETER NNX C.R. BARD, INC. (COVINGTON) -1018233 39303 JUEX2025 00801741071348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other