BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LUER-LOK¿ TIP

    MDR report key: 6875880 · Received September 19, 2017

    Report

    Report Number
    1213809-2017-00135
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    August 28, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER REPORTED. MEDICAL DEVICE LOT #: 7059871. MEDICAL DEVICE EXPIRATION DATE: 2/28/2012. DEVICE MANUFACTURE DATE: 02/28/2017. RESULTS - BD RECEIVED A PACKAGE FROM BATCH #7059871 (P/N 302995). THE PACKAGE WAS RECEIVED TORN OPEN. THE SYRINGE WAS FOUND TO HAVE UNIDENTIFIED FM (RED PARTICLE) ATTACHED TO EXTERIOR OF BARREL WALL. THE FM IS LARGER THAN LEVEL 3 IN SIZE, WHICH IS A REJECTABLE CONDITION AT BD CANAAN, HOWEVER THE SOURCE OF FM COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7059871. CONCLUSION - COMPLAINT CONFIRMED. HOWEVER, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI # (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND IN A GENERAL PURPOSE SYRINGE LUER-LOK¿ 10 ML INDIVIDUAL PACK LUER LOCK TIP WITHOUT SAFETY, PRIOR TO USE WITH NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657504 BD SYRINGE 10ML LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7059871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other