BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6761729 · Received August 2, 2017

    Report

    Report Number
    1213809-2017-00052
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 4, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. CUSTOMER SUBMITTED A PHOTO THAT DEPICTED A 3ML SYRINGE FILLED WITH CLEAR LIQUID. A SMALL GREY PIECE OF FOREIGN MATTER COULD BE SEEN ON THE STOPPER IN THE FLUID PATH. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #7001976. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, BASED ON THE SIZE AND THE COLOR, THE FM MOST LIKELY BECAME ATTACHED TO THE STOPPER IN THE STOPPER FEED DURING THE ASSEMBLY PROCESS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL GRAY PARTICLE WAS FOUND IN THE SYRINGE BARREL OF THE BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ BEFORE USE. THE SAMPLE WAS HANDLED IN A SAFETY CABINET AND NO MEDICAL INTERVENTIONS WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540009 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7001976

    Patients

    Seq Age Sex Outcome Treatment
    1 Other