BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 20706520 · Received November 18, 2024

    Report

    Report Number
    1920898-2024-05106
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 21, 2024
    Report Date
    February 10, 2025
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    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, B5, G6, H2, H3, H11. CORRECTION TO: H6 (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 UNABLE 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. 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

    MATERIAL - SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA. MATERIAL # - 324918. MATERIAL LOT# - 2192436 D. COMPLAINT DESCRIPTION - THE DOCTOR WAS USING A SYRINGE FILLED WITH BOTULINUM TOXIN AND AT THE TIME OF THE PROCEDURE SHE NOTICED THAT THE TOXIN WAS LEAKING THROUGH THE BODY OF THE SYRINGE, WASTING THE PRODUCT. THE SYRINGE WAS DEFECTIVE AND HAD A CRACK IN IT. THE PRODUCT WAS WASTED AT THE BEGINNING OF THE TREATMENT (WHEN WE DIDN'T KNOW WHAT WAS HAPPENING) AND THEN WHEN WE TRIED TO TRANSFER THE BOTULINUM TOXIN TO ANOTHER SYRINGE. THE LATTER PROCEDURE WAS UNSUCCESSFUL. ADDITIONAL NOTES - THE USER WOULD LIKE TO KNOW HOW THE COMPANY PROCEEDS IN THESE CASES OF MANUFACTURING DEFECT WITH INTENT ON THE PART OF THE PRODUCT USER.

    Description of Event or Problem · 0

    MATERIAL - SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA. MATERIAL # - 324918. MATERIAL LOT# - 2192436 D. COMPLAINT DESCRIPTION - THE DOCTOR WAS USING A SYRINGE FILLED WITH BOTULINUM TOXIN AND AT THE TIME OF THE PROCEDURE SHE NOTICED THAT THE TOXIN WAS LEAKING THROUGH THE BODY OF THE SYRINGE, WASTING THE PRODUCT. THE SYRINGE WAS DEFECTIVE AND HAD A CRACK IN IT. THE PRODUCT WAS WASTED AT THE BEGINNING OF THE TREATMENT (WHEN WE DIDN'T KNOW WHAT WAS HAPPENING) AND THEN WHEN WE TRIED TO TRANSFER THE BOTULINUM TOXIN TO ANOTHER SYRINGE. THE LATTER PROCEDURE WAS UNSUCCESSFUL. ADDITIONAL NOTES - THE USER WOULD LIKE TO KNOW HOW THE COMPANY PROCEEDS IN THESE CASES OF MANUFACTURING DEFECT WITH INTENT ON THE PART OF THE PRODUCT USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609560 SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 324918 2192436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female