BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    MDR report key: 7301130 · Received February 27, 2018

    Report

    Report Number
    1213809-2018-00067
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    February 2, 2018
    Report Date
    April 2, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TWO 1ML ASSEMBLED SYRINGES REPORTED TO BE FROM BATCH #7211534 (P/N 309626) WERE DEPICTED IN THE PHOTO. THE PHOTO WAS VISUALLY EVALUATED. ONE SYRINGE WAS MISSING THE NEEDLE CANNULA. THE CANNULA WAS OBSERVED TO BE IN THE MEDICINE VIAL. A NEEDLE CANNULA WHICH SEPARATES FROM THE NEEDLE HUB IS A REJECTABLE CONDITION. DHR REVIEW FOR BATCH 7211534 (P/N 309626): MANUFACTURING DATES: 07/31/2017 TO 08/2/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7211534 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE AND CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE OF A BD¿ TUBERCULIN SYRINGE WITH BD PRECISION GLIDE¿ DETACHABLE NEEDLE DISCONNECTED FROM THE HUB DURING A MEDICATION DRAW. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145020 BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 7211534 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other