BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60 ML BD SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 6751487 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00179
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    May 3, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A COMPLAINT HISTORY CHECK REVEALED NO SIMILAR INCIDENTS FOR REPORTED LOT NUMBER 6252655. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    A SMALL PARTICLE OF WHAT APPEARED TO BE PLASTIC BROKEN OFF OF A VIAL USED IN CRYOPRESERVATION WAS FOUND IN THREE BAGS OF STEM CELL PRODUCTS. MICHIGAN BLOOD HAS IDENTIFIED THE CAUSES OF PARTICLES DISCOVERED TO BE: THE STOPPER ON THE TOP OF A THERMO FISCHER VIAL USED TO MIX THE PRESERVATIVE DMSO BEING CHIPPED OFF IN THE COURSE OF THE NEEDLE PUNCTURING THE TOP OF THE VIAL DURING PRODUCT PREPARATION AND A SMALL PLASTIC PIECE COMING OFF OF THE 60 ML BD SYRINGE WITH BD LUER-LOK¿ TIP UTILIZED IN PRODUCT PREPARATION. THE PARTICLES FOUND APPEAR TO BE DIRECTLY RELATED TO THE MEDICAL SUPPLIES USED BY MICHIGAN BLOOD DURING CRYOPRESERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532572 60 ML BD SYRINGE WITH BD LUER-LOK¿ TIP HYPODERMIC SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 6252655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other