BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE/NDL, SAFETY 1CC 23GX1

    MDR report key: 11681125 · Received April 16, 2021

    Report

    Report Number
    3017368639-2021-00033
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 16, 2021
    Manufacturer
    GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
    Product Code
    MEG
    PMA / PMN Number
    141349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 # 210216-MH2). (B)(4) IS THE MANUFACTURER OF THE SYRINGE. MCKESSON MEDICAL-SURGICAL DOES NOT UNDERTAKE ANY FURTHER MANUFACTURING OR RELABELING OF THE SYRINGE. WE HAVE NOTIFIED (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

    THE CUSTOMER REPORTED THE FOLLOWING ISSUES WITH THE SAFETY SYRINGE: NEEDLE DETACHED FROM THE SYRINGE AND STAYED IN THE PATIENT'S ARM, NEEDLE SLID FROM CORRECT POSITION DOWN INTO THE SYRINGE, NEEDLE DID NOT HAVE A LEVEL, LEAKAGE FROM SIDES OF HUB, AND NEEDLE SELF-RETRACTING PRIOR TO ADMINISTRATION OF VACCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580285 SYRINGE/NDL, SAFETY 1CC 23GX1 MEG GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD 20JC2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other