BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21326724 · Received February 6, 2025

    Report

    Report Number
    8020040-2025-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Report Date
    February 5, 2025
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). RECEIVED 33PCS 450062/23D23D FOR EVALUATION. RECEIVED CUSTOMER PICTURES. ALSO RECEIVED 45PCS 450061/23F14C, WHICH THE CUSTOMER ADVISED WERE RETURNED IN ERROR. WE HAVE NO REMAINING INVENTORY OF THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT, CUSTOMER PICTURES, AND SAMPLES TO OUR SUPPLIER FOR THEIR INVESTIGATION AND COMMENTS. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED BATCH SHOWED NO ABNORMALITIES WHICH COULD BE RELATED TO THE REPORTED ISSUE. BOTH RETAIN AND CUSTOMER SAMPLES WERE VISUALLY CHECKED. NO BENT NEEDLES OR DAMAGED NEEDLE HUBS WERE OBSERVED. ADDITIONALLY, THE RIGIDITY TESTS CONDUCTED ON RETAIN AND CUSTOMER SAMPLES WERE WITHIN THE STANDARD RANGE. THE COMPLAINT CANNOT BE CONFIRMED. CORRECTED DATA: H6: COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER BUT HAVE NOT YET BEEN RECEIVED AT THE TIME OF THIS REPORT. IF AND WHEN CUSTOMER SAMPLES ARE RECEIVED, THEY WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. UPON COMPLETION OF THE COMPLAINT INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED THEIR TEAM TRIALED THE NEEDLES/HOLDERS. THE CUSTOMER ADVISED THEY EXPERIENCED SEVERAL REPORTS OF THE SAFETY BREAKING OFF THE HOLDER WHEN THE STAFF WAS TRYING TO ENGAGE THEM ONTO THE NEEDLE. CUSTOMER ADVISED IN ANOTHER INCIDENT, THE NEEDLE BROKE OFF WHILE TRYING TO ENGAGE THE SAFETY (PHOTOGRAPH PROVIDED). THE CUSTOMER ADVISED THE SAFETY DEVICE WAS ACTIVATED WITH A THUMB. CUSTOMER ADVISED NO DAMAGE TO PERFORATED SEAL, NEEDLE, HOLDER WAS NOTICED PRIOR TO USE. CUSTOMER ADVISED NEEDLES WERE ALIGNED AND SEATED STRAIGHT INTO HOLDERS PRIOR TO NEEDLE THREADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311842 VACUETTE® MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE NEEDLE, SHARPS FMI GREINER BIO-ONE GMBH 450062 23D23D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown