BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60 ML BD SYRINGE WITH BD LUER-LOK¿ TIP, BULK NON-STERILE

    MDR report key: 6751395 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00183
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    January 9, 2017
    Report Date
    July 28, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: ONE UNIT WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED UNIT CONFIRMED THE PRESENCE OF A SMALL FLY INSIDE THE SYRINGE BARREL, BEHIND THE STOPPER. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 6173973. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE BASED ON THE PROVIDED SAMPLE. OUR QUALITY ENGINEER CONCLUDES THAT THE FOREIGN WAS INTRODUCED DURING THE MANUFACTURING PROCESS. THIS IS CONSIDERED AN ISOLATED INCIDENT. (B)(4).

    Description of Event or Problem · 1

    A FLY WAS FOUND INSIDE THE 60 ML BD SYRINGE WITH BD LUER-LOK¿ TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532483 60 ML BD SYRINGE WITH BD LUER-LOK¿ TIP, BULK NON-STERILE HYPODERMIC SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 6173973

    Patients

    Seq Age Sex Outcome Treatment
    1 Other