BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML TB SYRINGE 27 G X 1/2 NEEDLE

    MDR report key: 6669448 · Received June 22, 2017

    Report

    Report Number
    MW5070634
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    June 21, 2017
    Report Date
    June 22, 2017
    Manufacturer
    B-D
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTS DEFECTIVE NEEDLE WITH SYRINGE - 1ML TB W/27G X 1/2" NDL (B-D): LOT # 7031969 CAV01, EXP 01/31/2022. SHE REPORTS THE NEEDLE WAS DISCOLORED AND ON THE HUB OF THE NEEDLE PT SAID THERE ARE 4 SQUARES AND ON ONE OF THEM THERE IS HARD CEMENT LIKE SUBSTANCE. PT ALSO MENTIONED THAT A PLASTIC PIECE WAS NOT ON THE SECTION. PT STATES DEFAULT WAS IN THE HUB OF THE NEEDLE SOMEHOW. THERAPY START DATE: (B)(6) 2017; THERAPY END DATE: (B)(6) 2017. PT USES SYRINGES FOR INTRON A 18MM UNIT/3 ML MDV 00085-1168-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442677 1 ML TB SYRINGE 27 G X 1/2 NEEDLE 1 ML TB SYRINGE 27 G X 1/2 NEEDLE FMF B-D 7031969 CAV01

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR