BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN.

    MDR report key: 6877546 · Received September 19, 2017

    Report

    Report Number
    1213809-2017-00121
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    August 24, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLE (INCLUDING PHOTOS) WERE RECEIVED FOR EVALUATION. HOWEVER, THE COMPLAINT IS CONFIRMED BASED ON THE FACT IT IS KNOWN, PREVIOUSLY REPORTED AND INVESTIGATED ISSUE WITH THIS LOT# (6001842). QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. REFER TO SITUATIONAL ANALYSIS MSS-16-800-SA AND CAPA #(B)(4). NO FURTHER ACTION IS REQUIRED AT THIS TIME. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLES WERE FOUND IN WRONG PACKAGING PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655086 BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN. SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other