BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® MULTIPLE USE DRAWING NEEDLE 22G X 1 1/4" BLACK, STERILE

    MDR report key: 15560396 · Received October 7, 2022

    Report

    Report Number
    8020040-2022-00031
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    July 19, 2022
    Report Date
    November 10, 2022
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT #: (B)(4). SAMPLES OF THE CUSTOMER WERE ONLY RECENTLY RECEIVED AND FORWARDED FOR INVESTIGATION TO THE MANUFACTURER, WHERE WE PURCHASE THE PRODUCT FROM. AS SOON AS THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4): RECEIVED (B)(4) PCS 450061/21I02D, AND (B)(4) PCS 450061/21G23C UNRELATED TO THE COMPLAINT. RECEIVED 100PCS 450061/21I02D FOR EVALUATION FROM CUSTOMER'S EARLIER SEPARATE COMPLAINT. NO CUSTOMER PICTURES WERE PROVIDED. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND CUSTOMER SAMPLES FROM THE PREVIOUS COMPLAINT TO OUR SUPPLIER FROM WHICH WE RECEIVE THESE PRODUCTS. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED MATERIAL/BATCH WERE REVIEWED, AND NO ABNORMALITIES COULD BE OBSERVED. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY EXAMINED. NO ABNORMALITIES SUCH AS DAMAGE WERE FOUND. THE RIGIDITY OF THE NEEDLE TUBES WAS TESTED; ALL WERE WITHIN THE RANGE OF STANDARDS. THE ALLEGED MALFUNCTION CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    CUSTOMER STATES: NEEDLESTICK AND SAFETY IS FLIMSY AND DID NOT COVER THE NEEDLE. DATE OF INJURY: (B)(6). GREINER BIO ONE NEEDLE. HOW INJURY OCCURRED: COMPLETED BLOOD DRAW, ENGAGING SAFETY LOCK, BUT IT DID NOT LOCK. PLACED ON TRAY, ONCE TIME OF DISPOSAL GRABBED IT AND PRICKED RT FINGER. "LIFE THREATENING?" NO. "PERMANENT DAMAGE?" NO. "MEDI/SURG INTERVENTION?" NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419083 VACUETTE® MULTIPLE USE DRAWING NEEDLE 22G X 1 1/4" BLACK, STERILE CANNULA FMI GREINER BIO-ONE GMBH 450061 21I02D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown