BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE/NDL, SAFETY 1CC 23GX1"

    MDR report key: 11612661 · Received April 5, 2021

    Report

    Report Number
    3017368639-2021-00014
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 3, 2021
    Manufacturer
    GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD
    Product Code
    MEG
    PMA / PMN Number
    141349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 # 210129-MH2. HAIOU MEDICAL 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 HAIOU MEDICAL, THE MANUFACTURER OF THE SYRINGE SO THEY MAY CONDUCT A DEVICE EVALUATION AS WARRANTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CONCERNS WITH THEIR SAFETY SYRINGES WHICH INCLUDED INCONSISTENCIES WITH THE RETRACTION MECHANISM AND NEEDLES BREAKAGE. ONE MALFUNCTION RESULTED IN A NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514272 SYRINGE/NDL, SAFETY 1CC 23GX1" MEG GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD 20JC2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other