BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGES

    MDR report key: 18939714 · Received March 20, 2024

    Report

    Report Number
    1000113657-2024-00119
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 2, 2024
    Report Date
    April 8, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    FMF
    UDI-DI
    00021292005856
    PMA / PMN Number
    K993017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). SYRINGES WERE NOT RETURNED FOR EVALUATION. NOTE: CUSTOMER CONTACT INFORMATION WAS NOT PROVIDED, MANUFACTURER UNABLE TO PERFORM FOLLOW-UP CALL TO CUSTOMER TO ENSURE THE INITIAL CONCERN IS RESOLVED.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 08-APR-2024: H10: SYRINGES WERE NOT RETURNED FOR EVALUATION. COMPLAINT WAS FORWARDED TO SUPPLIER QUALITY AND INTERNAL EVALUATION WAS PERFORMED BY THE MANUFACTURER USING SYRINGES FROM THE SAME LOT. NO ABNORMALITIES OBSERVED WITH RETENTION SAMPLES. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-009: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    CONSUMER COMPLAINT WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM (MW5151226). EVENT DESCRIPTION - MEDWATCH: PHARMACIST DISPENSING INSULIN SYRINGES FOUND A FEW SYRINGES IN A PACKAGE THAT WERE UNCAPPED AND SHE PRICKED HER FINGER; 1 ML INSULIN SYRINGES 30G X 5/16" NDC 56151-1723-11, LOT NP23075, EXP 04/16/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589037 SYRINGES PISTON SYRINGE FMF TRIVIDIA HEALTH INC SYR, NPD 1.0CC 30G 100CT5/16" 8/CS NP23075 00021292005856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown