BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11547354 · Received March 22, 2021

    Report

    Report Number
    8020040-2021-00014
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Report Date
    March 31, 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 450062 ONE BOX EACH: 20G13C AND 20F11C FOR EVALUATION. RECEIVED CUSTOMER PICTURES. 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 BATCHES SHOWED NO ABNORMALITY WHICH COULD BE RELATED TO THE REPORTED ISSUES. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY INSPECTED; NO BENT FRONT NEEDLE NOR ABNORMALITY SUCH AS DAMAGE ON NEEDLE HUB, RUBBER SLEEVE OR OTHER PARTS WAS FOUND. NEXT, THE RIGIDITY OF THE NEEDLE TUBES WAS TESTED; ALL WERE WITHIN THE RANGE OF STANDARDS. THEN, SAMPLES WERE CONNECTED TO GREINER HOLDERS AND BD TUBES INSERTED FOR WATER SAMPLING. AFTER REMOVING TUBES, NO LEAKAGE CAUSED BY RETRACTING DEFECT OR SIDE PENETRATION COULD BE FOUND. NO BREAKAGE OF NEEDLE TUBE AND NO NEEDLE TUBE SEPARATION FROM NEEDLE HUB DUE TO SCREW THREAD BREAKAGE WAS OBSERVED. FURTHERMORE, THE TENSILE STRENGTH OF THE RUBBER SLEEVES WAS MEASURED; ALL RESULTS WERE WITHIN RANGE OF STANDARDS. IN ADDITION, SILICONE APPLICATION ON THE BACK NEEDLE WAS MEASURED; ALL RESULTS WERE WITHIN RANGE OF STANDARD. NEEDLE HUBS WERE FURTHER VISUALLY INSPECTED; NO ABNORMALITY SUCH AS DAMAGE OR MOLDING DEFECT WAS FOUND. SCREWING TORQUE WAS MEASURED ON THE RETAIN SAMPLES. THE MAXIMUM TORQUE WAS 6.3CN·M (RETAIN SMP) AND 6.4CN·M (CUSTOMER SMP) ON BATCH# 20G13C, AND 6.7CN·M (RETAIN SMP) AND 6.3CN·M (CUSTOMER SMP) ON BATCH 20F11C. 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 WAS 23.9CN·M (RETAIN SMP) AND 23.6CN·M (CUSTOMER SMP) ON BATCH# 20G13C, AND 24.5CN·M (RETAIN SMP) AND 23.4CN·M (CUSTOMER SMP) ON BATCH 20F11C. NO SAMPLE HUB WAS BROKEN EASILY BY SCREWING INTO HOLDER. THE MINIMUM BREAKING TORQUE WAS MORE THAN TWICE THE SCREWING TORQUE. THE COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ORIGINALLY THE CUSTOMER STATED THAT THE NEEDLE BENT AS THE SAFETY WAS BEING ENGAGED VIA THUMB ACTIVATION. IN FOLLOW-UP COMMUNICATIONS, THE CUSTOMER ADVISED THAT BLOOD WAS LEAKING FROM THE NEEDLE. THE LEAKING STARTED WHERE THE NEEDLE CONNECTS TO THE HUB AND WAS CAUSING BLOOD TO GET ALL OVER THE PATIENT. THE PATIENT HAD 8 TUBES. THE RUBBER SLEEVE BEGAN LEAKING ON THE 5TH AND DISCONTINUED ON THE 7TH; SEVEN SSTS AND ONE LAVENDER TUBE, ALL BD TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445347 VACUETTE MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE CANNULA FMI GREINER BIO-ONE GMBH 450062 20G13C, 20F11C

    Patients

    Seq Age Sex Outcome Treatment
    1