BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 8203518 · Received December 28, 2018

    Report

    Report Number
    1213809-2018-00949
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 6, 2018
    Report Date
    January 4, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS OPENED MISTAKENLY AS A DUPLICATE OF REPORT# 1213809-2018-00964. THIS COMPLAINT WILL BE CANCELLED AND IS NO LONGER REPORTABLE. ALL INFORMATION FROM THIS COMPLAINT HAS BEEN CAPTURED IN 1213809-2018-00964.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH BLACK POINTS INSIDE SYRINGE.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT# K71649-1 DOES NOT MATCH WITH THE REPORTED CATALOG# SO THE MFR AND EXPIRATION DATES ARE UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH BLACK POINTS INSIDE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044148 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other