BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT®

    MDR report key: 13670962 · Received March 4, 2022

    Report

    Report Number
    3017368639-2022-00008
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 4, 2022
    Report Date
    March 2, 2022
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    UDI-DI
    00613703101600
    PMA / PMN Number
    K980069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT INCLUDE THIS SYRINGE COMPONENT. THE MANUFACTURER'S LOT NUMBER WAS CONFIRMED AS A LOT NUMBER THAT HAS 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 THE VANISH POINT SYRINGE IS FAULTY. WHILE THE NURSE WAS PUSHING DOWN ON THE PLUNGER OF THE SYRINGE, ALL OF THE CONTENTS LEAKED OUT OF THE SIDES OF THE SYRINGE AND LANDED ONTO THE PATIENT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669576 VANISHPOINT® 1ML SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC. 10161 G210841 00613703101600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other