BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B100L BD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES)

    MDR report key: 6622063 · Received June 8, 2017

    Report

    Report Number
    3009081593-2017-00007
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 16, 2017
    Report Date
    July 3, 2017
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    PMA / PMN Number
    K972878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. TWENTY FIVE RETENTION SAMPLES WERE VISUALLY INSPECTED AND NO NON-CONFORMANCES WERE OBSERVED. ACTIVATION FORCE MEASUREMENT ON FIVE PIECES AND MANUAL ACTIVATION ON 20 PIECES WERE PERFORMED. ALL RESULTS WERE WITHIN SPECIFICATION AND ALL DEVICES ACTIVATED SMOOTHLY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5041019. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY LOCKING MECHANISM OF A B100L BD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES) FAILED TO FUNCTION PROPERLY POST USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401973 B100L BD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES) PISTON SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) 5041019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other