BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 19395780 · Received May 24, 2024

    Report

    Report Number
    3024508819-2024-00078
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Report Date
    August 19, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    40 SYRINGES AFFECTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED FOUND WITH 4 BOXES, SAME ITEM NUMBERS, FINDING 1-2 SYRINGE PER 10 PACK WITH A LIQUID THAT COMES OUT OF THE NEEDLE BEFORE USE. HE FLICKS IT OFF THE NEEDLE TO USE. NOW SEEING THIS LIQUID IN HIS NOVOLIN CLEAR VIAL. - CALLER DID NOT CONTACT NOVO YET. DC LOT # 3233062 LOT # 1253645 CATALOG# 324909 DATE OF EVENT UNKNOWN SAMPLE STATUS AWAITING SAMPLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663531 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324909 1253645 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown