BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 31GA 6MM 10 BAG 500 NLA

    MDR report key: 21292266 · Received February 3, 2025

    Report

    Report Number
    3024508819-2025-00068
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    December 18, 2024
    Report Date
    June 26, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    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, H11. INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, SITUATION ANALYSIS EMBC-25-0003-SA AND CAPA PR-00048 WERE OPENED TO ADDRESS THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. 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 ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO DEFINITIVE ROOT CAUSE DETERMINED AT THIS TIME. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PHARMAPLUS HAS REJECTED 3 PRODUCT DELIVERIES IN MEXICO DUE TO DIVERGENCE IN THE EXPIRATION DATES OF THE PRODUCT FOUND ON THE INVOICE AND ON THE PRODUCT. 324915- BATCH: 3265263. 324913- BATCH: 4179003. 326785- BATCH: 4179008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157244 SYRINGE 1ML 31GA 6MM 10 BAG 500 NLA SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324915 3265263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown