BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12000097 · Received June 15, 2021

    Report

    Report Number
    8020040-2021-00025
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Report Date
    July 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

    NO FURTHER INFORMATION OR CLARIFICATION WAS RECEIVED FROM THE CUSTOMER ON THE SECOND INCIDENT. NO MATERIAL NUMBER WAS PROVIDED BY THE CUSTOMER. NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THIS PORTION OF THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED. RECEIVED 179PCS OF 450062/20G13C FOR EVALUATION. ALSO RECEIVED 1PC OF 450062/20J21C, WHICH WAS UNRELATED TO THE COMPLAINT. NO CUSTOMER PICTURES WERE PROVIDED. WE HAVE NO REMAINING INVENTORY OF THIS MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND CUSTOMER 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 ISSUE. NEEDLE HUBS OF CUSTOMER AND RETAIN SAMPLES WERE VISUALLY INSPECTED; NO ABNORMALITY SUCH AS DAMAGE OR MOLDING DEFECT WAS FOUND. A FITTING FORCE TEST WAS PERFORMED, ON BOTH THE RETAIN SAMPLES AND CUSTOMER SAMPLES, WITH A MAXIMUM REPORTED MEASUREMENT OF 6.3CN·M FOR THE RETAIN SAMPLES AND 7.2CN·M FOR THE CUSTOMER SAMPLES. ALL SAMPLES WERE SCREWED INTO HOLDER WITHOUT ANY PROBLEMS. IN ADDITION, EXCESSIVE TORQUE WAS APPLIED UNTIL HUB WAS DAMAGED TO OBTAIN THE BREAKING TORQUE. THE MINIMUM REPORTED BREAKAGE TORQUE WAS 23.9CN·M FOR THE RETAIN SAMPLES AND 24.8CN·M FOR THE CUSTOMER SAMPLES. NO SAMPLE HUB WAS BROKEN EASILY BY SCREWING INTO HOLDER. THE MINIMUM BREAKING TORQUE WAS MORE THAN TWICE THE SCREWING TORQUE. SAMPLES WERE THEN CONNECTED TO GREINER HOLDERS AND GREINER TUBES INSERTED FOR WATER SAMPLING. NO ABNORMALITY SUCH AS BREAKAGE ON NEEDLE TUBE OR DETACHMENT FROM SCREW THREAD ON NEEDLE HUB WAS OBSERVED. THIS PORTION OF 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 · 1

    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 · 1

    CUSTOMER STATES THE NEEDLE BROKE APART IN THE PATIENT'S ARM (ARTICLE 1). THIS OCCURRED WHEN THEY INSERTED THE NEEDLE INTO THE PATIENT'S ARM AND PROCEEDED TO INSERT TUBE INTO HOLDER. THE PHLEBOTOMIST ASSEMBLED THE NEEDLE AND HOLDER TOGETHER PROPERLY. NO ONE WAS HURT. THEY DID NOT RECEIVE A NEEDLESTICK. THE PATIENT DID NOT RECEIVE ANY BRUISING TO THE ARM. THEY DISCONTINUED THE DRAW AND CAREFULLY PLACED THE FAULTY NEEDLE AND HOLDER IN THE SHARP'S CONTAINER. THIS IS THE 2ND TIME AN INCIDENT HAS HAPPENED TO THIS PHLEBOTOMIST WITH THE NEW GREEN NEEDLES. ARTICLE 2 IS THE OTHER INCIDENT MENTIONED BY CUSTOMER. CUSTOMER STATES THE NEEDLE BROKE APART FROM THE HOLDER. THE NEEDLE WAS LEFT IN THE PATIENT'S ARM AND THE HOLDER IN HER HAND. THE NEEDLE DETACHED FROM THE HOLDER. THE BACKEND NEEDLE WAS STILL ATTACHED TO THE HOLDER. NO ITEM/LOT NUMBER AVAILABLE FOR ARTICLE 2 (OTHER INCIDENT). NO PHOTOS AVAILABLE. PRODUCT AVAILABLE TO RETURN FOR ARTICLE 1, LOT 20G13C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902158 VACUETTE MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE CANNULA FMI GREINER BIO-ONE GMBH 450062 20G13C

    Patients

    Seq Age Sex Outcome Treatment
    1