BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CATH PASSER 65CM

    MDR report key: 22310410 · Received June 23, 2025

    Report

    Report Number
    3014334038-2025-00083
    Event Type
    Malfunction
    Date Received
    June 23, 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
    OTHER
    Health Professional
    N

    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, G6, H1, H2, H3, H4, H6, H11. THE DISPOSABLE CATHETER (821517) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. 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.

    Description of Event or Problem · 0

    A FACILITY REPORTED THE PLASTIC TIP OF A DISPOSABLE CATHETER PASSER (ID 821517) BROKE OFF WITHIN THE PATIENT DURING SHUNT INSERTION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860180 DISPOSABLE CATH PASSER 65CM SHUNT,NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD 7358296 10381780515500

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female