BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7107283 · Received December 11, 2017

    Report

    Report Number
    1213809-2017-00396
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 3, 2017
    Report Date
    January 3, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON .COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    PHOTOS WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #6001842 (P/N 305916). THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, SEVERAL BD SAFETYGLIDE" NEEDLE PRODUCTS WERE FOUND PACKAGED AND LABELED INCORRECTLY. THERE WERE 0.5 INCH NEEDLES IN 1 INCH PACKAGING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883795 BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other