BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGES

    MDR report key: 7985734 · Received October 19, 2018

    Report

    Report Number
    1000113657-2018-01076
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    April 21, 2017
    Report Date
    October 19, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K9913017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED PRODUCT EVALUATED WITH DEFECT FOUND. QC EVALUATION ON (B)(6) 2017 RESULT IN REPORTED DEFECT FOUND; INSPECTED THE SUBJECT SYRINGE AND DID FIND A RATHER LARGE PIECE OF UNKNOWN (LOOKS LIKE A PLASTIC FILM) DEBRIS IN THE NEEDLE AREA. MLC-65: MANUFACTURING OR PACKAGING DEFECT BASED ON THE POST MARKET REVIEW (B)(4) AND REVIEW OF THE FDA'S TOTAL PRODUCT LIFE CYCLE (TPLC) - TOTAL DEVICE PROBLEMS, FOR POSSIBLE DELAY IN ADMINISTRATION OF INSULIN. REFERENCE - CAPA (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    THE PHARMACIST CALLED AND STATED WHEN HE OPEN THE BOXES OF SYRINGES, IT APPEARS THAT THERE IS A PIECE OF PLASTIC COVERING THE NEEDLES. NO ONE GOT STUCK WITH THE NEEDLES. HE IS JUST CONCERN ABOUT THE APPEARANCE. THE NDC NUMBERS ARE: (B)(4) 29G 0.5CC HE HAS 2 AND A HALF BOXES (B)(4) 29G 1CC. HE HAS HALF BOX. I ADVISE THE PHARMACIST THAT WE WILL BE SENDING 4 BOXES OF THE GNP SYRINGES FOR HIM. HE ALREADY TRIED TO CALL HIS SUPPLIER AND WAS ADVISE TO CALL US. HE STATED THIS IS NOT THE FIRST TIME THIS HAS HAPPENED BUT HE HAD DISCARDED THE SYRINGES. I ADVISE HIM IN THE FUTURE TO CALL US AND NOT TO DISCARD THE PRODUCTS SINCE WE NEED IT FOR INVESTIGATION. I WILL REPLACE 4 BOX OF INSULIN NEEDLES AND HE WILL SEND THE OTHERS BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826155 SYRINGES BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. SYRINGES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR