BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 21857904 · Received April 17, 2025

    Report

    Report Number
    3023359743-2025-00297
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: 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 NOT 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 THE PATIENT END IS BENDING WHEN TAKING INJECTIONS. STATED, THE PATIENT END BROKE OFF IN HIS INJECTION SITE TWICE WHEN HE WAS TAKING HIS INJECTION BUT HE WAS ABLE TO REMOVE THE NEEDLES. DID NOT SEEK MEDICAL INTERVENTION STATED, HE PURCHASED 4 BOXES WITH THE SAME LOT NUMBER BUT ONLY OPENED ONE BOX. STATED, HE IS NOT COMFORTABLE CONTINUING TO USE THE PRODUCT AND WILL BE DONATING THE BOXES HE DID NOT OPEN LOT: 4030372. CATALOG: 320109. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764041 PEN NDL 31GA 8MM 100 BX 1200 USA Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320109 4030372 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male