BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20ML ENTERAL SYRINGE

    MDR report key: 6730650 · Received July 20, 2017

    Report

    Report Number
    1911916-2017-00030
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    January 5, 2017
    Report Date
    July 17, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #:5231588, MEDICAL DEVICE EXPIRATION DATE: 08/25/2020, DEVICE MANUFACTURE DATE: 08/19/2015. MEDICAL DEVICE LOT #:5306664, MEDICAL DEVICE EXPIRATION DATE: 10/31/2020, DEVICE MANUFACTURE DATE: 11/02/2015. MEDICAL DEVICE LOT #: 5356765, MEDICAL DEVICE EXPIRATION DATE: 12/31/2020, DEVICE MANUFACTURE DATE: 12/22/2015. MEDICAL DEVICE LOT #:5356766, MEDICAL DEVICE EXPIRATION DATE: 12/31/2020, DEVICE MANUFACTURE DATE: 12/22/2015. ONE SAMPLE WITHOUT PACKAGING WAS RETURNED FOR EVALUATION. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED AN ORANGE PIECE OF PLASTIC INSIDE THE BARREL. A DHR REVIEW WAS NOT CONDUCTED. CONCLUSION: ALTHOUGH THE INVESTIGATION CONFIRMED ORANGE PLASTIC IN THE DEVICE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT WAS NOT DETERMINED. THE MANUFACTURING SITE WAS MADE AWARE OF THIS INCIDENT FOR CUSTOMER AND QUALITY AWARENESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ORANGE PLASTIC SHARD WAS FOUND IN THE BARREL OF THE BD¿ 20ML ENTERAL SYRINGE. NO INJURY OR MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508526 BD¿ 20ML ENTERAL SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other