BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE

    MDR report key: 9634502 · Received January 27, 2020

    Report

    Report Number
    1213809-2020-00018
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    December 9, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059042
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (SYRINGE). PMA / 510(K)#: K951254 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE HAD "1"" NEEDLES FOUND IN THE PACKAGING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OFFICE IS REPORTING THEY ARE GETTING 1" NEEDLES IN 5/8" PACKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98472 BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305904 9255272 30382903059042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other