BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

    MDR report key: 20694038 · Received November 15, 2024

    Report

    Report Number
    1018233-2024-07234
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 25, 2024
    Report Date
    April 9, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. PHOTO: RECEIVED TWO (2) PHOTO SAMPLES. FIRST PHOTO SAMPLE SHOWCASES AN ISC BOX WITH LABEL THAT SHOWS PCN (53616G), LOT NUMBER (JUJS0787), AND EXPIRATION DATE (2029-05-28). SECOND PHOTO SAMPLES SHOWCASE TWO (2) UNOPENED ISCS. ONE (1) ISC HAS DOUBLE SIDED TAPE AND THE OTHER ONE (1) DOES NOT HAVE DOUBLE SIDED TAPE. BASED ON THE PHOTO SAMPLES RECEIVED AND THE WAIVER ISSUANCE 03-2024-022, THE PRODUCT MEETS SPECIFICATIONS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME SINCE ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT NECESSARY DUE TO THE REPORTED EVENT BEING UNCONFIRMED. AS THE REPORTED EVENT WAS UNCONFIRMED, A LABELING REVIEW WAS 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 THE ADHESIVE TAB WAS NOT ON THE INTERMITTENT CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADHESIVE TAB WAS NOT ON THE INTERMITTENT CATHETER (LOT#JUJT1029). PER CUSTOMER VIA EMAIL RESPONSE ON 10DEC2024, IT WAS REPORTED THAT CUSTOMER SUBMITTED A PHOTO SAMPLE OF AFFECTED (LOT#JUJS0787). CUSTOMER REPORTED THAT THIS WAS A PACKAGING STICKER RELATED ISSUE FOUND PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196296 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE INTERMITTENT CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 JUJT1029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other