BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROPSAFE

    MDR report key: 15781069 · Received November 11, 2022

    Report

    Report Number
    3017368639-2022-00031
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 18, 2022
    Report Date
    October 28, 2022
    Manufacturer
    HTL STREFA S A
    Product Code
    FMI
    UDI-DI
    85907996099319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT CAN CONTAIN THE DEVICE FROM THE MANUFACTURER IDENTIFIED. THE ITEM REF # AND LOT # REPORTED AND IDENTIFIED IN SECTION D HAVE BEEN CONFIRMED AS HAVING BEEN USED IN THE ASSEMBLY OF CONVENIENCE KITS SUPPLIED BY MCKESSON MEDICAL-SURGICAL, INC. WE HAVE NOTIFIED (B)(6) FOR AWARENESS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN ISSUE WITH THE STREFA PRODUCT SUPPLIED IN THE KIT, INDICATING THAT THE SAFETY DOESN'T ALWAYS LATCH RIGHT AWAY. CUSTOMER STATED THAT IT TAKES MORE PRESSURE TO GET THE SAFETY TO ENGAGE. THE CUSTOMER PROVIDED MANUFACTURER PRODUCT # 6059 AND LOT # SN25250018 AS ADDITIONAL PRODUCT IDENTIFICATION INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199857 DROPSAFE 25G DROPSAFE SAFETY NEEDLE FMI HTL STREFA S A 25G SN25250018 85907996099319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown