BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LM

    MDR report key: 11568170 · Received March 25, 2021

    Report

    Report Number
    3017540467-2021-00002
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 25, 2021
    Manufacturer
    YANGZHOU MEDLINE INDUSTRY CO, LTD.
    Product Code
    MEG
    PMA / PMN Number
    K170651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 (B)(4), THAT INCLUDES THIS SAFETY NEEDLE. YANGZHOU MEDLINE INDUSTRY MANUFACTURES THE NEEDLE THAT IS INCLUDED IN THE ANCILLARY ADULT CONVENIENCE KIT (1176194, LOT 210217-GB1). MCKESSON MEDICAL-SURGICAL DOES NOT UNDERTAKE ANY FURTHER MANUFACTURING OR RELABELING OF THE NEEDLE. WE HAVE NOTIFIED (B)(4) WHO WILL PASS ALONG THIS INFORMATION TO YANGZHOU MEDLINE INDUSTRY, THE MANUFACTURER OF THE NEEDLE SO THEY MAY CONDUCT A DEVICE EVALUATION AS WARRANTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT NEEDLES ARE BREAKING AND/OR BENDING IN VIALS AND PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469988 LM NEEDLE, SAFETY 23GX1 1/2" MEG YANGZHOU MEDLINE INDUSTRY CO, LTD. SN201209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other