BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 15651366 · Received October 21, 2022

    Report

    Report Number
    3017368639-2022-00028
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 22, 2022
    Report Date
    October 21, 2022
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    UDI-DI
    00613703101600
    PMA / PMN Number
    K980069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT CAN CONTAIN THE DEVICE FROM THE MANUFACTURER IDENTIFIED IN SECTION D. THE ITEM REF # AND LOT # REPORTED AND IDENTIFIED IN SECTION D HAVE BEEN CONFIRMED AS HAVING BEEN USED IN THE ASSEMBLY OF CONVENIENCE KITS SUPPLIED BY MCKESSON MEDICAL-SURGICAL, INC. WE HAVE NOTIFIED (B)(6) AND (B)(6) FOR AWARENESS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT IMMEDIATELY AFTER REMOVING A RETRACTABLE TECHNOLOGIES VANISHPOINT SYRINGE FROM ITS WRAPPER, THEY SAW LIQUID CONTAINED INSIDE OF THE BARREL OF THE SYRINGE. THE SYRINGE WAS REPORTED AS A TUBERCULIN SYRINGE WITH NEEDLE, VANISHPOINT® 1 ML 25 GAUGE 1 INCH REGULAR WALL RETRACTABLE SAFETY NEEDLE. MANUFACTURER MODEL# 10161, LOT # G210954. ADDITIONAL PRODUCT INFORMATION IS CONTAINED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241781 VANISHPOINT SAFETY NEEDLE, 1 ML 25 GAUGE X 1" MEG RETRACTABLE TECHNOLOGIES, INC. 10161 G210954 00613703101600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other