BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUETTE MULTIPLE USE DRAWING NEEDLES 22GX1"

    MDR report key: 9742063 · Received February 21, 2020

    Report

    Report Number
    8020040-2016-00020
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    July 6, 2016
    Report Date
    February 21, 2020
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (COMPLAINT (B)(4)). ACCORDING TO THE INFORMATION PROVIDED BY THE SUPPLIER THE CONTAMINATION OF THE NEEDLE WITH THE OIL WAS CAUSED BY AN OPERATIOR ERROR DURING THE PRODUCTION PROCESS - DURING A ROUTINE MAINTENANCE STEP THE OPERATOR FORGOT TO TURN OFF THE MACHINE. FURTHER THE SUPPLIER SENT THE AFFECTED LOT TO GBO (B)(4) ALTHOUGH IT WAS AGREED NOT TO DO SO WITHOUT THE RELEASE OF GBO (B)(4). ALL ITEMS, WHICH ARE IN THE WAREHOUSE OF GBO (B)(4), HAVE BEEN BLOCKED IMMEDIATELY. THOSE PRODUCTS WHICH HAVE ALREADY BEEN DELIVERED WILL BE RECALLED.

    Description of Event or Problem · 1

    DURING THE INCOMING GOODS INSPECTION OF THE ITEM (450072, 16B15A) ONE NEEDLE WAS FOUND TO BE SOILED WITH OILY PARTICLES ON THE PATIENT SIDE NEEDLE. LOT 16B15A WAS BLOCKED, IRREGULARITY REPORT WAS SENT TO SUPPLIER AND THE SUPPLIER WAS INFORMED, THAT THE AFFECTED LOT WON'T BE ACCEPTED BY GBO (B)(4). SUPPLIER INFORMED GBO (B)(4), REGARDING THE ROOT CAUSE AND THE AFFECTED ITEMS (LAST 10 CARTONS OF PRODUCTION) AND THAT AFFECTED PRODUCTS HAVE ALREADY BEEN SENT TO GBO (B)(4). DUE TO THE FACT THAT GBO (B)(4) HAS NOT DONE AN INCOMING GOODS INSPECTION ERROR WAS NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205339 VACUETTE MULTIPLE USE DRAWING NEEDLES 22GX1" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI GREINER BIO-ONE GMBH 450072 16B15A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention