BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ML BD¿ TUBERCULIN SYRINGE, 27GX1/2" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    MDR report key: 6418798 · Received March 20, 2017

    Report

    Report Number
    1213809-2017-00014
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 24, 2017
    Report Date
    April 18, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: EIGHT UNUSED AND SEALED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED NO EXTRA ADHESIVE WAS FOUND ON OR AROUND THE SHIELDS. THE SYRINGES WERE TESTED FOR SHIELD REMOVAL FORCE AND THE RESULTS WERE WITHIN SPECIFICATIONS. TWO OF THE SAMPLES WERE ABOVE THE AVERAGE REMOVAL FORCE BUT STILL WITHIN SPECIFICATIONS. SPECIFICATIONS FOR SHIELD REMOVAL FORCE IS FROM GREATER THAN OR EQUAL TO .5 LBS TO LESS THAN OR EQUAL TO 5.5 LBS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6241524. 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 NEEDLE CAP OF THE SUSPECT DEVICE IS DIFFICULT TO REMOVE. THIS HAS RESULTED IN APPROXIMATELY 10-15 PRE USE NEEDLE STICK INJURIES TO THE DOCTOR. NO MEDICAL INTERVENTIONS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199589 1ML BD¿ TUBERCULIN SYRINGE, 27GX1/2" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE TUBERCULIN SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6241524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other