BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, SAFETY 25GX1 1/2"

    MDR report key: 11677315 · Received April 16, 2021

    Report

    Report Number
    3017368639-2021-00032
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 15, 2021
    Manufacturer
    YANGZHOU MEDLINE INDUSTRY CO, LTD.
    Product Code
    MEG
    PMA / PMN Number
    K170651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 NEEDLE. YANGZHOU MEDLINE INDUSTRY MANUFACTURES THE NEEDLE THAT IS INCLUDED IN THE ADULT ANCILLARY 1170 MASTER CONVENIENCE KIT (1183217). MCKESSON MEDICAL-SURGICAL DOES NOT UNDERTAKE ANY FURTHER MANUFACTURING OR RELABELING OF THE NEEDLE. WE HAVE NOTIFIED (B)(6) 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

    THE CUSTOMER REPORTED THAT THE NEEDLES BEND AND COME APART FROM THE SYRINGE DURING THE ADMINISTRATION OF VACCINES. NEEDLES ARE BENDING AND DULL AND HARD TO INSERT INTO THE ARM. MCKESSON DID NOT RECEIVE ANY INFORMATION REGARDING DIRECT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579926 NEEDLE, SAFETY 25GX1 1/2" MEG YANGZHOU MEDLINE INDUSTRY CO, LTD. 201113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other