BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CATH PASSER 65CM

    MDR report key: 13077341 · Received December 23, 2021

    Report

    Report Number
    3014334038-2021-00263
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 23, 2021
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K944222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI): (B)(4). THE DISPOSABLE CATHETER PASSER (821517) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE); 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 PHYSICIAN REPORTED THAT WHEN THE PERITONEAL CATHETER WAS CONNECTED TO THE INNER CYLINDER, THE CATHETER PASSER CAME OFF AND COULD NOT PASSED THROUGH. THE PROCEDURE WAS COMPLETED BY TYING WITH A THREAD USING A SURGICAL SONDE. THE EVENT LED TO MORE THAN 30 MINUTES SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978234 DISPOSABLE CATH PASSER 65CM SHUNT,NERVOUS SYSTEM & COMPS JXG RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male