BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15552334 · Received October 6, 2022

    Report

    Report Number
    8020040-2022-00029
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 2, 2022
    Report Date
    November 17, 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

    (B)(4). WE DID NOT RECEIVE ANY SAMPLES OR MORE DETAILED INFORMATION ON THE LOT NUMBER. THE INCIDENT WAS REPORTED FOR INVESTIGATION TO THE MANUFACTURER WHERE WE PURCHASE THE PRODUCT FROM, BUT A RESPONSE WAS NOT YET RECEIVED. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RECEIVED 184PCS 450061/21K01D, 200PCS 450061/21K05D, AND 41PCS 450061/21G23C FOR EVALUATION. NO CUSTOMER PICTURES WERE PROVIDED. WE HAVE NO FURTHER INVENTORY OF THE CLAIMED MATERIALS/BATCHES. WE FORWARDED THE COMPLAINT AND CUSTOMER SAMPLES TO OUR SUPPLIER FROM WHICH WE RECEIVE THESE PRODUCTS. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED MATERIALS/BATCHES 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 WAS NOT 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) 2022. GREINER BIO ONE 22GX1¼ NEEDLE. HOW INJURY OCCURRED: COMPLETED BLOOD DRAW, MOVED TO INITIATE NEEDLE SAFETY DEVICE, SAFETY NEEDLE DID NOT FULLY ENGAGE AND NEEDLE PUNCTURED RIGHT INDEX FINGER. LIFE THREATENING? NO. PERMANENT DAMAGE? NO. MEDI/SURG INTERVENTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2898257 VACUETTE® MULTIPLE USE DRAWING NEEDLE 22G X 1 1/4" BLACK, STERILE CANNULA FMI GREINER BIO-ONE GMBH 450061 21K01D, 21K05D, 21G23C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown