BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 19387402 · Received May 23, 2024

    Report

    Report Number
    3023359743-2024-00114
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K213478
    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, H2, H3, H11. CORRECTION TO: D3 (COUNTRY TYPE AND COUNTRY), 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 THAT THE NEEDLES WILL NOT ATTACH. CONSUMER SAID THAT HE MADE SEVERAL COMPLAINTS FOR THE SAME ISSUE WITH OTHER BOXES AND HAS RECEIVED SEVERAL REPLACEMENTS BUT THE ISSUE IS NOT BEING RESOLVED. HE ALSO STATED THAT HE WAS TOLD THAT HE MUST LINE UP THE NEEDLE WITH THE PEN BEFORE TIGHTENING THE NEEDLE, BUT HE SAID IT IS IMPOSSIBLE TO DO THAT. CONSUMER HAD THE SAME ISSUE WHILE USING NANO 2ND GEN PEN NEEDLES. A COMPLAINT WAS DOCUMENTED ON SF(B)(4). LOT #: 3038612 CATALOG #: 320122 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054849 PEN NDL 32G 4MM 100BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320122 3179369 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown