BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE QUICKSHIELD SAFETY TUBE HOLDER

    MDR report key: 12438934 · Received September 8, 2021

    Report

    Report Number
    1125230-2021-00067
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 11, 2021
    Report Date
    October 13, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    FMI
    PMA / PMN Number
    K033478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 20 LOOSE PIECES OF 450230/B21023L9 FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO FURTHER INVENTORY OF THIS MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THIS MATERIAL/BATCH. A REVIEW OF QUALITY AND PRODUCTION RECORDS REVEALED NO DEVIATIONS IN ASSOCIATION WITH THE REPORTED ISSUES. CUSTOMER SAMPLES WERE VISUALLY EVALUATED. ALL SAMPLES WERE CONFIRMED TO BE CORRECTLY ASSEMBLED, AND NO DEVIATIONS WERE NOTED. SAMPLES WERE FUNCTIONALLY CHECKED TO ENSURE PROPER ACTIVATION OF THE SAFETY MECHANISM. AFTER PROPERLY THREADING A MULTI-SAMPLE NEEDLE INTO EACH QUICKSHIELD, THE SAFETY MECHANISMS FOR TEN SAMPLE PIECES WERE ACTIVATED ACCORDING TO OUR IFU USING THE STABLE SURFACE TECHNIQUE, AND TEN SAMPLE PIECES WERE ACTIVATED ACCORDING TO OUR IFU USING THE THUMB/FINGER TECHNIQUE. ALL SAFETY SHIELDS ENGAGED PROPERLY, CLICKING INTO PLACE WITHOUT BENDING OF THE NEEDLES. THE REPORTED EVENT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAFETY HOLDER WAS USED TOGETHER WITH THE NEEDLE, ITEM 450062 - SEE MDR 8020040-2021-00033. SAMPLES FROM THE CUSTOMER WERE ONLY RECENTLY RECEIVED. AS SOON AS THE INVESTIGATION OF THE EVENT IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER STATES WHEN THE PSR (PHLEBOTOMIST) ATTEMPTED TO ENGAGE THE SAFETY SHIELD FROM THE BASE,THE NEEDLE BENT AND THE PSR WAS STUCK BY DIRTY NEEDLE. THE DATE OF OCCURRENCE WAS (B)(6) 2021. USED ANOTHER NEEDLE/HUB (HOLDER) FROM THE SAME LOTS AND THE NEEDLE BENT AGAIN. THE INCIDENT WAS REPORTED BY THE END USER TO QUEST EHS FOR FOLLOW UP AND PROPER TREATMENT FOR THE PSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341551 VACUETTE QUICKSHIELD SAFETY TUBE HOLDER TUBE HOLDER FMI GREINER BIO-ONE NA INC. 450230 B21023L9

    Patients

    Seq Age Sex Outcome Treatment
    1