BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

    MDR report key: 20683371 · Received November 14, 2024

    Report

    Report Number
    1018233-2024-07194
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 23, 2024
    Report Date
    May 6, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741069789
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED- PRODUCT MET SPECIFICATIONS. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. PHOTO: RECEIVED TWO (2) PHOTO SAMPLES. BOTH PHOTO SAMPLES SHOWCASE FOUR (4) UNOPENED ISCS. ONE (1) ISC HAD DOUBLE SIDED TAPE, THE OTHER TWO (2) ISCS DID NOT HAVE DOUBLE SIDED TAPE, AND THE FOURTH ISC UNABLE TO DETERMINE. BASED ON THE PHOTO SAMPLES RECEIVED AND THE WAIVER ISSUANCE 03-2024-022, THE PRODUCT MEETS SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT NECESSARY DUE TO THE REPORTED EVENT BEING UNCONFIRMED. A LABELING REVIEW IS NOT REQUIRED. CORRECTION: D, E, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE INTERMITTENT CATHETER DUE TO THE ADHESIVE MISSING. THEY WERE ABLE TO GET REPLACEMENT PRODUCT SENT, HOWEVER THE REPLACEMENT PRODUCT ALSO WAS MISSING THE ADHESIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE INTERMITTENT CATHETER DUE TO THE ADHESIVE MISSING. THEY WERE ABLE TO GET REPLACEMENT PRODUCT SENT, HOWEVER THE REPLACEMENT PRODUCT ALSO WAS MISSING THE ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350105 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE INTERMITTENT CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 JUJS1246 00801741069789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other