BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGES

    MDR report key: 5592117 · Received April 20, 2016

    Report

    Report Number
    1052693-2016-00761
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 21, 2016
    Report Date
    April 20, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    FMF
    PMA / PMN Number
    K993017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SYRINGE PACKAGE IN QUESTION WAS DISPOSED - THE CUSTOMER HAS NOT PRODUCT TO RETURN. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: MANUFACTURING DEFICIENCY.

    Description of Event or Problem · 1

    COMPLAINT REPORTED VIA EMAIL ON (B)(4) 2016 IN REGARDS TO SYRINGES. FACILITY ((B)(6)) STATES THE SYRINGE BAG WAS SEALED AND CAPS WERE OFF NEEDLES. THE NEEDLES POKED THROUGH THE BAG AND POKED THE CARE TAKER ((B)(6)). THE NEEDLE GAUGE IS 33, LOT NP1314 AND EXPIRATION DATE 160313. REBECCA HENDERSON REPORTS: WHEN PACKAGE WAS RECEIVED FROM PHARMACY AND (B)(6) PICKED UP PACKAGE WITH SYRINGES, SYRINGE PROTRUDED THROUGH THE SYRINGE PACKAGE AND PHARMACY PACKAGING AND IT PIERCED HER FINGER. WHEN INCIDENT OCCURRED (B)(6) WAS NOT WEARING GLOVES. AREA LANCED WAS NOT RED OR INFECTED. SHE IMMEDIATELY CONTACTED (B)(6) (PHARMACIST AT (B)(6) PHARMACY). ONE SYRINGE OUT OF TWO PACKAGES THAT WERE RECEIVED HAD CAP OFF. SYRINGE PACKAGE IN QUESTION WAS DISPOSED OF IN SHARPS CONTAINER. NO MEDICAL INTERVENTION WAS NEEDED. (B)(6) HAS NO FURTHER CONCERN ABOUT INCIDENT THAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248601 SYRINGES BLOOD GLUCOSE SYSTEM FMF TRIVIDIA HEALTH, INC. TRUEPLUS NP1314

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR