BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA

    MDR report key: 21057821 · Received January 2, 2025

    Report

    Report Number
    3024508819-2025-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 29, 2024
    Report Date
    February 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 PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTIONS H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS) AND H10 (RELATED REPORT NUMBERS). 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 COULD BE IDENTIFIED; HOWEVER. PROBABLE ROOT CAUSE IS THE PRESENCE OF OTHER MANUFACTURING MATERIALS IN THE PROCESS FLOW. THIS BATCH WAS MANUFACTURED IN AUG2023 AND CAPA PR-00016 WAS COMPLETED IN FEB2024 FOR FM INSIDE SYRINGE. THEREFORE, CORRECTIVE ACTION HAS BEEN CREATED SINCE THIS BATCH WAS CREATED. 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

    INFORMATION FROM AE REGULATORY SYSTEM: ON (B)(6) 2024, WHEN NURSE WAS PREPARING TO INJECT INSULIN TO PATIENT, A RED FOREIGN MATTER WAS FOUND ON CANNULA WHEN OPENED A NEWLY PACKED AND INTACT DISPOSABLE STERILE INSULIN SYRINGE. SYRINGE WAS IMMEDIATELY REPLACED WITH A NEW ONE FOR USE. IT WAS DISCOVERED BEFORE SYRINGE WAS USED ON THE PATIENT AND DID NOT CAUSE ANY HARM TO THE PATIENT. NO OTHER DEVICE USED. AE REPORT NO. (B)(4). CALL CENTER CONTACTED CUSTOMER TO ACQUIRE THE INFORMATION: THE INFORMATION REPORTED IN THE AE REGULATORY SYSTEM EXISTS. IN ADDITION, CUSTOMER SUPPLEMENTED INFORMATION: THERE ARE PHOTOS TAKEN, NO SAMPLES RETAINED, AND NO CUSTOMER RESPONSE IS NEEDED. CUSTOMER COULD NOT ACQUIRE THE MATERIAL CODE, MATERIAL CODE IN SYSTEM: 328421. SAMPLE AVAILABILITY: YES. SAMPLE AVAILABILITY DETAILS: PICTURE/VIDEO ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349619 SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328421 3065162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose