BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 ML BD¿ TB SYRINGE WITH 27G X 1/2IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    MDR report key: 6190151 · Received December 20, 2016

    Report

    Report Number
    1213809-2016-00049
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 19, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: 14 SEALED SAMPLES WERE RETURNED FOR EVALUATION. THE SAMPLES WERE TESTED FOR SHIELD REMOVAL FORCE. THE MAXIMUM SHIELD REMOVAL FORCE SPECIFICATION IS 5.5 LBS. OF THE 14 SAMPLES, ONE FAILED WITH A SHIELD REMOVAL FORCE OF 5.94 LBS.. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6241524. CONCLUSION: ALTHOUGH THE CUSTOMER'S INDICATED FAILURE MODE WAS CONFIRMED, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. OUR QUALITY ENGINEER STATES THE SAMPLE SIZE RECEIVED FROM CUSTOMER (14 PIECES) DOES NOT REPRESENT THE OVERALL QUANTITY RELEASED FOR BATCH (B)(4). ONE SYRINGE OUT OF THE 14 RECEIVED WAS FOUND TO BE OUT OF SPEC. (B)(4). AT THIS POINT THIS COMPLAINT IS CONSIDERED AN ISOLATED EVENT SINCE NO ISSUES WERE IDENTIFIED DURING PROCESS AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. NO ADDITIONAL ACTION IS RECOMMEND FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BD (B)(4) WILL CONTINUE MONITORING OUR MANUFACTURING PROCESSES TO ENSURE PRODUCT QUALITY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE STICK INJURY OCCURRED BEFORE PATIENT USE WITH A 1 ML BD TB SYRINGE WITH 27G X 1/2IN. BD PRECISIONGLIDE DETACHABLE NEEDLE THAT WAS FILLED WITH "STEP BACTERIA". THE INITIAL REPORTED INDICATED THAT THIS HAPPENED BECAUSE THE NEEDLE CAP WAS TOO TIGHT AND SHE HAD DIFFICULTY REMOVING THE CAP. AFTER THE INJURY OCCURRED, THE CLINICIAN WENT TO EMPLOYEE HEALTH WHERE SHE WAS EVALUATED AND RECEIVED A TETANUS IMMUNIZATION. SHE DID NOT RECEIVE ANY LAB WORK OR ANY OTHER MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839805 1 ML BD¿ TB SYRINGE WITH 27G X 1/2IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE TUBERCULIN SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6241524

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention