BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE

    MDR report key: 11495776 · Received March 16, 2021

    Report

    Report Number
    8020040-2021-00013
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Report Date
    April 7, 2021
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 158PC 450062/19H08C FOR EVALUATION. RECEIVED CUSTOMER PICTURE. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT, CUSTOMER SAMPLES AND PICTURE TO OUR SUPPLIER FOR THEIR INVESTIGATION AND COMMENTS. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED MATERIAL/BATCH SHOWED NO ABNORMALITY WHICH COULD BE RELATED TO THE REPORTED ISSUE. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY INSPECTED; NO BENT NOR BROKEN FRONT NEEDLE WAS FOUND. NEXT, THE RIGIDITY OF THE NEEDLE TUBES WAS TESTED; ALL WERE WITHIN THE RANGE OF STANDARDS. THE COMPLAINT COULD NOT BE DUPLICATED. CORRECTED DATA: H3: DEVICE EVALUATED BY MANUFACTURER; H6: INVESTIGATION METHOD, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. THE SAMPLES WERE JUST RECENTLY OBTAINED AND FORWARDED TO THE SUPPLIER OF THE PRODUCT FOR AN EVALUATION. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES NEEDLES BROKE OFF; ONE PRIOR TO DRAW AND THE OTHER IN THE MIDDLE OF ENGAGING. CLARIFICATION HAS BEEN REQUESTED ON "IN THE MIDDLE OF ENGAGING". PRODUCT SPECIALIST HAS BEEN MADE AWARE OF THE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396808 VACUETTE MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE CANNULA FMI GREINER BIO-ONE GMBH 450062 19H08C

    Patients

    Seq Age Sex Outcome Treatment
    1