BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® QUICKSHIELD SAFETY TUBE HOLDER

    MDR report key: 13758056 · Received March 14, 2022

    Report

    Report Number
    3007817041-2022-00002
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Report Date
    April 21, 2022
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K033478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED. NO SAMPLES OR PICTURES WERE RECEIVED. AN INFORMATION ON THE EVENT WAS SENT TO THE SUPPLIER WHO WE PURCHASE THE PRODUCT FROM. AS SOON AS THEIR INVESTIGATION IS COMPLETED, A SUPPLEMENTAL SUBMISSION WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO REMAINING INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND CUSTOMER PICTURES TO OUR AFFILIATED HEADQUARTERS IN AUSTRIA FROM WHICH WE RECEIVED THIS PRODUCT. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, A REVIEW OF PRODUCTION DOCUMENTATION REVEALED NO DEVIATIONS WHICH COULD BE ASSOCIATED WITH THE REPORTED ERROR. A TECHNICAL AND FUNCTIONAL INSPECTION OF THE ASSEMBLY LINE WAS PERFORMED, AND NO DEVIATIONS WERE OBSERVED. CURRENT PRODUCTION WAS CHECKED, AND NO DEVIATIONS WERE DETECTED. THE CAUSE OF THE ALLEGED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATES PSR [PHLEBOTOMIST] SUSTAINED A NEEDLESTICK WHEN ATTEMPTED TO ENGAGE THE HUB'S [HOLDER] SAFETY DEVICE. THEY ENGAGED THE SAFETY DEVICE ON A HARD SURFACE CAUSING THE GUARD TO BREAK AND BEND THE NEEDLE RESULTING IN A NEEDLESTICK ON HER LEFT WRIST. CUSTOMER PROVIDED PICTURES OF DEVICE. THE EE STATED ON TRIPLE I REPORT "AFTER DRAWING THE PATIENT I WENT TO ENGAGE THE SAFETY GUARD ON THE NEEDLE, THE SAFETY GUARD BROKE OFF AND I GOT POKED BY THE NEEDLE ON THE LT WRIST INNER". THE NEEDLE INVOLVED IN THE INCIDENT WAS 21 G, ITEM 450062, EXTERNAL LOT 21D21C [INTERNAL LOT B210446Y]. NO UNUSED HOLDERS AVAILABLE TO RETURN FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415367 VACUETTE® QUICKSHIELD SAFETY TUBE HOLDER SAFETY HOLDER FMI GREINER BIO-ONE GMBH 450230 G210738V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown