BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 6749672 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00034
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    January 6, 2017
    Report Date
    July 20, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 6102543 MFG DATE 4/1/2016 EXP DATE 04/30/2021. LOT NUMBER: 5259928 MFG DATE 9/1/2015 EXP DATE 09/30/2020. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: EXAMINATION OF THE RETURNED SAMPLES CONFIRMED THE INDICATED ISSUE. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF SILICONE. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR LOT'S 6102543, AND 5259928 NO DEFECTS WERE FOUND. CONCLUSION: SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. UDI #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS TWO DIFFERENT INCIDENTS OF FOREIGN MATTER IN THE FLUID PATHWAY WITH A 30 ML BD LUER-LOK¿ TIP SYRINGE. NO MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530907 30 ML BD LUER-LOK¿ TIP SYRINGE SYRINGE, LUER-LOK FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other