BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ COUDE INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

    MDR report key: 20724185 · Received November 19, 2024

    Report

    Report Number
    1018233-2024-07315
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 29, 2024
    Report Date
    May 6, 2025
    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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. FIRST PHOTO SAMPLE SHOWCASE AN ISC BOX WITH LABEL THAT SHOWS PCN (50614), LOT NUMBER (JUJU9019), EXPIRATION DATE (2029-06-28), AND QUANTITY IN BOX (30). SECOND PHOTO SAMPLE SHOWCASES TWO (2) ISCS WITH NO BLUE DOUBLE-SIDED TAPE ATTACHED. 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. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY STATED THERE WERE A BLUE PIECE MISSING FROM THE PRODUCT IN INTERMITTENT CATHETER. CUSTOMER DISCUSSED THAT THE PHOTO OF THIS PRODUCT HAD A GREEN SLEEVE. CUSTOMER ORDERED 6 BOXES AND 5 WERE AFFECTED. PER CUSTOMER FOLLOW UP RECEIVED VIA PHONE ON 07DEC2024 NOTICED WRAPPER WAS MISSING ARROW BEFORE USING OF MY UNDERSTANDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY STATED THERE WERE A BLUE PIECE MISSING FROM THE PRODUCT IN INTERMITTENT CATHETER. CUSTOMER DISCUSSED THAT THE PHOTO OF THIS PRODUCT HAD A GREEN SLEEVE. CUSTOMER ORDERED 6 BOXES AND 5 WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334388 MAGIC3¿ COUDE INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE INTERMITTENT CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 JUJU9019 00801741068089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other