BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEBREAK VASCULAR

    MDR report key: 16460396 · Received March 1, 2023

    Report

    Report Number
    3019511659-2022-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    July 18, 2022
    Report Date
    February 24, 2023
    Manufacturer
    LINEUS MEDICAL
    Product Code
    QOI
    PMA / PMN Number
    DEN190043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE IS UNABLE TO BE DETERMINED. ALTHOUGH THE FAILURE MODE WAS REPLICATED, THE CONDITIONS NECESSARY TO REPLICATE THE FAILURE WERE WAY OUTSIDE NORMAL USE CONDITIONS AND REQUIRED THE USE OF A TOOL TO GAIN LEVERAGE DIRECTLY AT THE WELD. IN ORDER TO BETTER UNDERSTAND THE ROBUSTNESS OF THE WELD UNDER A PREVIOUSLY UNEXPECTED LOADING CONDITION, CANTILEVER BEAM TESTING WAS PERFORMED AND PASSED THE ACCEPTANCE CRITERIA. IN ORDER TO CONTROL AND MONITOR THIS LOADING CONDITION MOVING FORWARD, THE CANTILEVER BEAM TEST WILL BE ADDED TO FULL WELD VALIDATION FOR THE PATIENT END WELD. NO DESIGN CHANGES ARE WARRANTED AT THIS TIME. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR THIS EVENT TYPE. NOTE: THE REPORT IS OUTSIDE OF 30-DAY REPORTING PERIOD BECAUSE LINEUS MEDICAL WAS IN THE ENROLLMENT PROCESS FOR ELECTRONIC SUBMISSION. IN ADDITION, THE FDA ELECTRONIC SUBMISSION GATEWAY (HTTPS://ESG.FDA.GOV/LOGIN ) WAS INITALLY USED FOR THE SUBMISSION AND ON 10/13/2022 NOTIFICATIONS OF RECEIPT AND ACKNOWLEDGMENT OF THE SUBMISSION WERE RECEIVED AND I TOOK THEM AS A SIGN OF A SUCCESFUL SUBMISSION. LATER WHEN CHECKING IF THE RERPOT WAS PUBLIC AND NOT FOUND, I CONTACTED THE FDA OFFICE AND THEY GUIDED ME TO USE ESUBMITTTED INSTEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE BROKE DURING USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SAFEBREAK VASCULAR WAS CONNECTED TO A NEEDLELESS CONNECTOR THAT WAS CONNECTED TO THE PRIMARY TUBING OF A INTERNAL JUGULAR (IJ) CENTRAL LINE PORT. ONE OF THE IV NURSES, WHO WAS CALLED TO ASSESS THE PORT FOR LACK OF BLOOD RETURN, NOTICED THE IV ADMINISTRATION LINE WAS NOT CONNECTED. IT IS UNKNOWN WHEN SAFEBREAK WAS INSTALLED. NORMAL SALINE WAS INFUSING AT THE TIME; NO MEDICATION WAS INFUSING. THE SAFEBREAK WAS FOUND TO NOT TO HAVE SEPARATED WHERE INTENDED, BUT RATHER 'BROKE'. THE PATIENT SIDE LUER REMAINED CONNECTED TO THE PATIENT LINE AND IV SIDE LUER REMAINED CONNECTED TO THE IV TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844818 SAFEBREAK VASCULAR SAFEBREAK VASCULA QOI LINEUS MEDICAL 2855-01-0001 11319

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| O