BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LM

    MDR report key: 11560619 · Received March 24, 2021

    Report

    Report Number
    3017540467-2021-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    March 2, 2021
    Report Date
    March 23, 2021
    Manufacturer
    YANGZHOU MEDLINE INDUSTRY CO, LTD.
    Product Code
    MEG
    PMA / PMN Number
    K170651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 NEEDLE. YANGZHOU MEDLINE INDUSTRY CO, LTD. MANUFACTURES THE NEEDLE THAT IS INCLUDED IN THE CONVENIENCE KIT. MCKESSON MEDICAL SURGICAL DOES NOT UNDERTAKE ANY FURTHER MANUFACTURING OR RELABELING OF THE NEEDLE. THE KIT IS THE ANCILLARY ADULT CONVENIENCE KIT. LOT NUMBER OF THE KIT WAS NOT REPORTED BY THE CUSTOMER. WE HAVE NOTIFIED THE GOVERNMENT AT THE FOLLOWING ADDRESSES: (B)(6) OF THIS REPORT WHO WILL PASS ALONG THIS INFORMATION TO YANGZHOU MEDLINE INDUSTRY CO, LTD, THE MANUFACTURER OF THE NEEDLE SO THEY MAY CONDUCT A DEVICE EVALUATION AS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED, AND ONE STAFF MEMBER SUSTAINED A SHARPS INJURY. STAFF ARE REPORTING DIFFICULTY ACTIVATING THE SAFETY FEATURE AFTER A JAB AND DIFFICULTY ENGAGING THE SAFETY LOCK. THE ENGAGING MECHANISM ON THIS NEEDLE IS A HINGE ABOUT 3/8" ABOVE THE HUB. WHEN SCREWED DOWN, THE LUER DOES NOT HOLD THE NEEDLE TIGHT AND WHEN ATTEMPTING TO ENGAGE THE LOCK, THE WHOLE THING POPS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463480 LM NEEDLE, SAFETY 23GX1" MEG YANGZHOU MEDLINE INDUSTRY CO, LTD. SN201110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other