BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE TUBING SET FOR VERSICON

    MDR report key: 7683295 · Received July 12, 2018

    Report

    Report Number
    3005083075-2018-00002
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    October 7, 2015
    Report Date
    July 12, 2018
    Manufacturer
    JOIMAX GMBH
    Product Code
    FQH
    UDI-DI
    04250337105640
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER FACILITY AND WAS NOT AVAILABLE FOR EVALUATION, THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED TO CONFIRM OR DENY A DEVICE MALFUNCTION. A REVIEW OF SIMILAR COMPLAINTS REVEALED THE ROOT CAUSE AS USE ERROR WHERE THE LUER-LOCK CONNECTOR WAS NOT TIGHTENED APPROPRIATELY. THERE WERE NO OTHER COMPLAINTS OF LEAKS FROM THIS MANUFACTURING LOT. THE DEVICE HISTORY RECORDS FOR THIS MANUFACTURING LOT WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    JOIMAX BECAME AWARE OF A MAUDE REPORT FILED BY A HEALTHCARE FACILITY ALLEGING THAT DURING PREPARATION FOR SURGERY THE VERSICON TUBING SET LEAKED. THE FACILITY REPORTS THAT THE LEAKING TUBING WAS REMOVED FROM THE FIELD, DISCARDED, AND REPLACED WITH A NEW TUBING SET WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF INJURY. BECAUSE THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS THE INVESTIGATION WAS INCONCLUSIVE AS TO WHETHER THE EVENT WAS ATTRIBUTED TO DEVICE MALFUNCTION OR USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522553 SINGLE USE TUBING SET FOR VERSICON LAVAGE JET, FQH JOIMAX GMBH JTSB350D 04052015 04250337105640

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR