BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 11612690 · Received April 5, 2021

    Report

    Report Number
    3017368639-2021-00016
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 20, 2021
    Report Date
    April 3, 2021
    Manufacturer
    RETRACTABLE TECHNOLOGIES
    Product Code
    MEG
    PMA / PMN Number
    K980069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL SURGICAL IS THE ASSEMBLER OF A CONVENIENCE KIT ON BEHALF OF THE SNS THAT INCLUDES THIS SAFETY SYRINGE. THE KIT IS THE 1183217 ADULT ANCILLARY 1170 MASTER CONVENIENCE KIT (LOT # 210111-MI1). RETRACTABLE TECHNOLOGIES IS THE MANUFACTURER OF THE SYRINGE. MCKESSON MEDICAL-SURGICAL DOES NOT UNDERTAKE ANY FURTHER MANUFACTURING OR RELABELING OF THE SYRINGE. (B)(6). WHO WILL PASS ALONG THIS INFORMATION TO RETRACTABLE TECHNOLOGIES, THE MANUFACTURER OF THE SYRINGE SO THEY MAY CONDUCT A DEVICE EVALUATION AS WARRANTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON TWO OCCASIONS, THE SAFETY MECHANISM FAILED DURING ADMINISTERING A VACCINE. MCKESSON DID NOT RECEIVE ANY INFORMATION REGARDING DIRECT PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513749 VANISHPOINT SYRINGE/NDL, VANISH POINT 1CC25GX1" RETRAC MEG RETRACTABLE TECHNOLOGIES G200926

    Patients

    Seq Age Sex Outcome Treatment
    1 Other