BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US

    MDR report key: 19505568 · Received June 10, 2024

    Report

    Report Number
    3023359743-2024-00170
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Report Date
    September 12, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, EMBECTA WAS ABLE TO CONFIRM THIS COMPLAINT AND ROOT CAUSE WAS IDENTIFIED. A SITUATION ANALYSIS WAS COMPLETED AND CAPA OPENED TO ADDRESS THE REPORTED ISSUE. THIS IS THE 13TH OF 18TH 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (TYPE OF INVESTIGATION & 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 18TH 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

    SEVERAL PHARMACY ADDRESSES FROM SAME PHARMACY CHAIN REPORTED TO EMBECTA REP "THE PEN NEEDLES WERE RECEIVED BACK INTO THE INVENTORY SYSTEM WITH AN INCORRECT EXPIRY DATE. THE DATE THAT WAS ENTERED INTO THE SYSTEM WAS OCTOBER 5, 2025 AND THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED WAS FEBRUARY 29, 2024. TMAIK 10JUNE2024: EMBECTA WAS INFORMED BY OUR DISTRIBUTOR RR DONNELLEY THAT THEY RECEIVED COMPLAINTS FROM 18 CUSTOMERS REGARDING THIS EVENT. THIS COMPLAINT COVERS ONE OF THE 18 COMPLAINTS RECEIVED BY RR DONNELLEY. TMAIK 10JUNE2024: ¿TO CLARIFY, THE EXPIRY DATE LABELED ON THE PRODUCT IS CORRECT (FEB 29, 2024). DUE TO MANUAL ERROR WITH ENTERING THE EXPIRY DATE IN THE DISTRIBUTOR SYSTEM, THE PRODUCT WAS SHIPPED PAST ITS LABELED EXPIRY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10227 PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320551 / 320553 (BULK) 9044773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown