BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12000347 · Received June 15, 2021

    Report

    Report Number
    8020040-2021-00026
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Report Date
    June 28, 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 100PC 450062/19H12C FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO FURTHER INVENTORY OF THE 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 ABNORMALITIES SUCH AS DAMAGES OR MOLDING DEFECTS ON THE NEEDLE HUB COULD BE OBSERVED. FITTING FORCE TEST WAS MEASURED ON THE CUSTOMER AND RETAIN SAMPLES. THE MAXIMUM WAS 6.4CN·M AND 7.1CN·M RESPECTIVELY. ALL SAMPLES WERE SCREWED INTO HOLDER WITHOUT ANY BREAKAGE. IN ADDITION, EXCESSIVE TORQUE WAS APPLIED UNTIL HUB WAS DAMAGED TO OBTAIN THE BREAKING TORQUE. THE MINIMUM WAS 24.6CN·M AND 24.9CN·M RESPECTIVELY. NO SAMPLE HUB WAS BROKEN EASILY BY SCREWING INTO HOLDER. THE MINIMUM BREAKING TORQUE WAS MORE THAN TWICE THE SCREWING TORQUE. FURTHERMORE, SAMPLES WERE CONNECTED TO GREINER HOLDERS AND BLOOD COLLECTION TUBES INSERTED FOR SAMPLING. NO ABNORMALITIES SUCH AS BREAKAGE OR DETACHMENT COULD BE OBSERVED. THE COMPLAINT COULD NOT BE DUPLICATED. CORRECTED DATA: H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE REQUESTED FROM THE CUSTOMER TO BE FORWARDED TO THE SUPPLIER WHERE WE PURCHASE THE PRODUCT FROM. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER STATES THE NEEDLE HOLDER DETACHED FROM THE STRAIGHT NEEDLE COMPLETELY. THE NEEDLE WAS IN THE PATIENT'S ARM UNSUPPORTED. SINCE THE TRANSITION TO THE GREINER NEEDLES AT THIS SITE, THE STAFF HAS NOT BEEN HAPPY WITH THE NEW NEEDLES AND COMPLAINTS STARTED IMMEDIATELY. THEY FEEL THEY ARE CHEAPLY MADE AND HAVE A DIFFERENT FEEL FROM WHAT THEY WERE USING BEFORE. TO THE CUSTOMER'S KNOWLEDGE, THIS IS THE ONLY OCCURRENCE. NO INJURY TO THE NURSE AND NO INJURY TO THE PATIENT. HOLDER IN USE WAS 450230/G201135H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902162 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