BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS CONTAINER 1.4 QT HOME

    MDR report key: 19201872 · Received April 29, 2024

    Report

    Report Number
    3022699058-2024-00002
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 5, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EMBECTA MEDICAL II LLC - PARSIPPANY, NJ
    Product Code
    FMI
    UDI-DI
    00382903234875
    PMA / PMN Number
    K943139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H11 INVESTIGATION SUMMARY: THE INVESTIGATION IS CURRENTLY IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A DETAILED SUMMARY WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT HER HOME SHARPS CONTAINER HAD A LARGE HOLE AT THE BOTTOM. IT APPEARED THAT THE CONTAINER WAS MELTED WHERE THE HOLE WAS FORMED. LOT #: 3157001 CATALOG #: 323487 DATE OF EVENT: 04-05-24 SAMPLES: AVAILABLE - SENDING MAIL KIT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022398 SHARPS CONTAINER 1.4 QT HOME NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC - PARSIPPANY, NJ 323487 3157001 00382903234875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown