BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12438813 · Received September 8, 2021

    Report

    Report Number
    8020040-2021-00033
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 28, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 395PCS OF 450062/20L09C FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO REMAINING INVENTORY OF THIS MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THIS MATERIAL/BATCH. WE FORWARDED THE COMPLAINT, CUSTOMER SAMPLES AND PICTURES 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 ISSUE. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY INSPECTED; NO BENT FRONT NEEDLE NOR ABNORMALITY RELATED TO THE REPORTED EVENT WAS FOUND. THE RIGIDITY OF THE NEEDLE TUBES WAS ALSO TESTED; ALL WERE WITHIN THE RANGE OF STANDARDS. THE NEEDLE PART OF THE PRODUCT CONCERNED IS STRONG ENOUGH TO MEET INTERNATIONAL STANDARDS. HOWEVER, IT MAY BE DEFORMED OR DAMAGED IF THE LOAD EXCEEDS THIS LIMIT. THE COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). THE NEEDLE WAS USED TOGETHER WITH THE QUICKSHIELD SAFETY HOLDER, ITEM 450230 - SEE MDR 1125230-2021-00067. SAMPLES FROM THE CUSTOMER WERE ONLY RECENTLY RECEIVED AND FORWARDED TO THE SUPPLIER, WHERE WE PURCHASE THE NEEDLE FROM. AS SOON AS THE INVESTIGATION OF THE EVENT WILL BE 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 (B)(6) FOR FOLLOW UP AND PROPER TREATMENT FOR THE PSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341483 VACUETTE MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE CANNULA FMI GREINER BIO-ONE GMBH 450062 20L09C

    Patients

    Seq Age Sex Outcome Treatment
    1