BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 CA

    MDR report key: 19359665 · Received May 21, 2024

    Report

    Report Number
    3023359743-2024-00109
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TOTAL OF 3 LOTS IMPACTED. SEE COMPLETED MEDWATCH FORM SECTION C ATTACHED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H3, H11. CORRECTION PROVIDED IN D3 (COUNTRY TYPE), H6 (TYPE OF INVESTIGATION, INVESTIGATION CONCLUSION). 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

    PHARMACIST REPORTED ISSUE ON BEHALF OF CONSUMER. STATED, THE CONSUMER RETURNED A BOX WITH MIXED PRODUCT. STATED, ALL OF THE PEN NEEDLES WERE 32G, 4MM BUT SOME ARE LABELED MICRO FINE AND SOME ARE LABELED NANO PRO LOT: 3234701, (NANO PRO PER PHARMACIST) CATALOG: 320555 2243157 & 3018824- (MICRO FINE PER PHARMACIST, 32G, 4MM) DID NOT HAVE CATALOG NUMBER. PUT THE LOTS ON ONE COMPLAINT BECAUSE PHARMACIST STATED, NEEDLES FROM THE THREE LOTS WERE IN ONE BOX. DATE OF EVENT: UNKNOWN SAMPLES: YES CL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604732 PEN NDL 32G 4MM PRO 100 BOX 1200 CA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320555 3234701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown