BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11657441 · Received April 13, 2021

    Report

    Report Number
    8020040-2021-00020
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Report Date
    April 21, 2021
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 1 INNER BOX 450062/19H12C FOR EVALUATION. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND SAMPLES TO OUR SUPPLIER FOR THEIR INVESTIGATION AND COMMENTS. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED BATCH SHOWED NO ABNORMALITY WHICH COULD BE RELATED TO THE REPORTED ISSUES. CAPS (GREY COVER) OF RETAIN AND CUSTOMER SAMPLES WERE REMOVED IN ORDER TO VISUALLY INSPECT THE APPEARANCE OF THE NEEDLE HUB AND CONTAINER (GREEN COVER). NO LOOSE CONNECTION OR DETACHMENT COULD BE OBSERVED. NO ABNORMALITY SUCH AS BREAKAGE OR MOLDING DEFECT WAS FOUND. NEXT, FITTING TEST BETWEEN THE NEEDLE HUB AND CONTAINER WAS PERFORMED. ALL RESULTS WERE FOUND TO BE WITHIN RANGE OF STANDARDS AND NO CONDITION WAS OBSERVED WHICH WOULD ALLOW THE CONTAINER TO COME OFF EASILY. THE COMPLAINT COULD NOT BE DUPLICATED. CORRECTED DATA:E1: NAME OF ESTABLISHMENT; H3: SAMPLES EVALUATED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). NO DATE OF EVENT COULD BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE RECEIVED AND FORWARDED FOR EVALUATION TO THE HEADQUARTER, WHERE WE BUY THE PRODUCT FROM. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES, TWICE ON THE SAME PATIENT, PHLEBOTOMIST REMOVED THE GRAY COVER OF THE BACK END NEEDLE AND THE GREEN COVER ALSO CAME OFF. ALSO, 1 INCIDENT WHERE GRAY COVER OF THE BACK END NEEDLE WAS REMOVED AND THE NEEDLE WAS ALREADY STICKING OUT. MORE CLARIFICATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558113 VACUETTE MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE CANNULA FMI GREINER BIO-ONE GMBH 450062 19H12C

    Patients

    Seq Age Sex Outcome Treatment
    1