BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXFR CYSTOSCOPY IRR

    MDR report key: 9880194 · Received March 25, 2020

    Report

    Report Number
    9615050-2020-00048
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 3, 2020
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    GBX
    UDI-DI
    10887787006732
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - RECEIVED ONE USED LIST# 065440403 WITH THE COMPLAINT OF THE PIERCING PIN BREAKING DURING BAG ACCESS. AS RECEIVED, THE SET WAS VISUALLY INSPECTED AND THE PIERCING PIN WAS FOUND TO BE BROKEN AT THE TIP. NO OTHER ANOMALIES WERE FOUND DURING THE INSPECTION. THE BAG THAT THE SPIKE WAS USED TO ACCESS WAS NOT RETURNED FOR EVALUATION, NOR WAS THE BROKEN PIN'S TIP. THE DIMENSIONS OF THE BROKEN SPIKE WERE MEASURED AND FOUND TO BE WITHIN SPEC WHERE APPLICABLE. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE BREAK IS DUE TO PIERCING PIN DESIGN WHICH HAS BEEN DEEMED UNABLE TO WITHSTAND ALL CLINICAL STRESSES. A DEVICE HISTORY REVIEW (DHR) FOR LOT# 4102714 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. TESTING IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A LTXFR CYSTOSCOPY IRR WHERE THE PRONG OF THE CONTINUOUS BLADDER IRRIGATION TUBING SET BROKE OFF AFTER THE BAG WAS SPIKED AND THE PRONG WAS SEEN FLOATING IN THE FLUID OF THE BAG. THERE WAS PATIENT INVOLVEMENT, BUT THE BROKEN PRONG WAS NOTICED AND THE TUBING OR BAG CHANGED OUT BEFORE IT REACHED THE PATIENT. THERE WERE NO FRAGMENTS PASSING THROUGH THE TUBING SET. THERE WAS NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343663 LTXFR CYSTOSCOPY IRR CATHETER, IRRIGATION GBX ICU MEDICAL COSTA RICA LTD. 654401 4102714 10887787006732

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPEC SOLUTION CONTAINER, MFR UNK