BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA

    MDR report key: 20768677 · Received November 24, 2024

    Report

    Report Number
    1213809-2024-00878
    Event Type
    Malfunction
    Date Received
    November 24, 2024
    Date of Event
    November 5, 2024
    Report Date
    December 24, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. IT IS POSSIBLE THE "FM/STICKY GEL SUBSTANCE¿ OBSERVED IN THE SYRINGE IS SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF (B)(4) UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT.

    Description of Event or Problem · 0

    MATERIAL: 305270. BATCH#: 4214081. IT WAS REPORTED THAT THE BD INTEGRA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. (B)(6). RESIDUE INSIDE THE SYRINGE. REF: (B)(4). LOT 4214081. SAMPLES ARE AVAILABLE. CUSTOMER WOULD LIKE TO KNOW IF THEY CAN USE THE PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213880 BD INTEGRA SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 4214081 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown