BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CATH PASSER 65CM

    MDR report key: 22054099 · Received May 20, 2025

    Report

    Report Number
    3014334038-2025-00064
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 30, 2025
    Report Date
    October 31, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780515500
    PMA / PMN Number
    K944222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE DISPOSABLE CATHETER PASSER (ID 821517) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT WAS DISCARDED AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. ADDITIONAL INFORMATION: "THE PASSER BROKE WHILE THE SURGEON WAS TUNNELING. IT WAS IN THE SUBCUTANEOUS TISSUE, IDENTIFIED BY X-RAY OR CT SCAN (CAN'T REMEMBER) AND REMOVED AT THE PATIENT BEDSIDE THE NEXT DAY. THERE WAS NO PATIENT HARM OTHER THAN HAVING TO HAVE IT REMOVED."

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE TIP AT THE END OF A DISPOSABLE CATHETER PASSER ID(B)(6) BROKE OFF DURING SURGERY AND HAD TO BE REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM. NO ADDITIONAL SURGERY WAS REQUIRED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182049 DISPOSABLE CATH PASSER 65CM SHUNT,NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD 7480890 10381780515500

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female