BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 14 PACK

    MDR report key: 24081635 · Received January 15, 2026

    Report

    Report Number
    3027605735-2026-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 26, 2025
    Report Date
    January 15, 2026
    Manufacturer
    EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED, INVESTIGATION WAS PERFORMED ON RETAIN SAMPLES AND NO ISSUES WERE OBSERVED, 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-CONFORMANCE'S 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

    AN EMBECTA EMPLOYEE CALLED TO REPORT THAT ON THE MORNING ON DECEMBER 26TH, A NURSE IN THE NEUROLOGY DEPARTMENT OF XX HOSPITAL USED THE SAME INJECTION PEN TO ADMINISTER INSULIN TO DIFFERENT PATIENTS (EACH PATIENT WAS INJECTED WITH A NEW NEEDLE, NEEDLE WAS NOT REUSED). DURING NEEDLE REPLACEMENT, OUTER COVER ONLY REMOVED THE NEEDLE HUB, THE CANNULA STILL ON THE PEN, RESULTING IN THE NURSE WAS NEEDLE STICKED. MATERIAL CODE: 329491, LOT NUMBER: 4180011. THE NURSE TOOK APPROPRIATE PROFESSIONAL MEASURES, BUT IT'S UNKNOWN THAT WHETHER THERE WAS ANY BLOOD INFECTION. THE PROBLEMATIC NEEDLE HAS BEEN DISCARDED, AND NO NEW NEEDLES FROM THE SAME BATCH COULD BE PROVIDED FOR FURTHER INVESTIGATION. THE HOSPITAL HOPES THAT SIMILAR INCIDENTS WILL NOT OCCUR AGAIN AND A PHONE CALLED CUSTOMER RESPONSE IS REQUIRED. SAMPLE AVAILABILITY: NO. SAMPLE AVAILABILITY DETAILS: NO SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145951 PEN NEEDLE 32GX4MM 14 PACK Needle, hypodermic, single lumen FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 000000000000329491 4180011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female