BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR NVS STEIN

    MDR report key: 9112361 · Received September 24, 2019

    Report

    Report Number
    3001741852-2019-00053
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K011369 / K122558. INVESTIGATION SUMMARY: UNCONFIRMED, NO SAMPLE PROVIDED. INVESTIGATION CONCLUSION: BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. ROOT CAUSE DESCRIPTION: AS SAMPLES WERE NOT PROVIDED A TRUE ROOT CAUSE COULD NOT BE ESTABLISHED AND LINKED TO A BD SWINDON PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING OR MATERIAL DEFECTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. AS SUCH THE COMPLAINT IS BEING CLOSED WITHOUT CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE ULTRASAFE X100L PNG CLEAR NVS STEIN THE TWO SYRINGES IN A KIT ARE DISSEMBLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO SYRINGES IN A KIT ARE DISSEMBLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907725 ULTRASAFE X100L PNG CLEAR NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON 6189317

    Patients

    Seq Age Sex Outcome Treatment
    1 Other