BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 19779088 · Received July 18, 2024

    Report

    Report Number
    3024508819-2024-00191
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 17, 2024
    Report Date
    October 10, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382903249107
    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

    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

    FROM: [email protected] <[email protected]> SENT: TUESDAY, JUNE 25, 2024 1:39 AM. TO: PRODUCTCOMPLAINTS <[email protected]> SUBJECT: DIRECT CONSUMER 2024-06-17 PRODUCT INQUIRY - INQUIRY REF: [ REF: (B)(4)]. FROM: [email protected] <[email protected]> SENT: TUESDAY, JUNE 25, 2024 1:39 AM. TO: PRODUCTCOMPLAINTS <[email protected]> SUBJECT: DIRECT CONSUMER 2024-06-17 PRODUCT INQUIRY - INQUIRY REF: [ REF:(B)(4)]. DIRECT CONSUMER 2024-06-24 PRODUCT INQUIRY - INQUIRY REF: CONSUMER REPORTED COULD NOT DRAW HIS INSULIN BECAUSE HE BELIEVES THE NEEDLES ARE BLOCKED. LOT: 3128169. CATALOG: 324910. DATE OF EVENT: 2024-06-24. SAMPLES: NO. 3 SYRINGES AFFECTED. DECLINED TO PROVIDE ADDRESS AND DECLINED REPLACEMENT. EMAIL CAME INTO OUTLOOK BUT DID NOT COME INTO SALESFORCE. CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499586 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324910 3128169 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male