BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN115 23G 1IN BP

    MDR report key: 10022116 · Received May 4, 2020

    Report

    Report Number
    2243072-2020-00713
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 13, 2020
    Report Date
    May 12, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-04-16. H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2912231 THERE IS NO ISSUE WHILE MANUFACTURING. 1 SAMPLE WAS RETURNED TO SBDM. BASED ON IR ANALYSIS, SBDM INDICATED THE FM IS SAME COMPONENT WITH MATERIAL OF RUBBER PORT IN THE VIAL (POLY(ISOPRENE) WHICH IS A NATURAL RUBBER). FROM INVESTIGATION, SBDM SUPPOSE THAT THE SPIKE WAS PIERCED THROUGH THE RUBBER PORT, FRAGMENT OF RUBBER PORT SEPARATED AND THEN IT FLOWED INTO THE I.V SET LINE. IT MIGHT BE OCCURRED WHEN TOO SHARP INJECTION HOLE IN THE SPIKE TIP IS PIERCED TOO SOFT VIAL RUBBER. AS PER KOREAN STANDARD AND SPECIFICATION OF MEDICAL DEVICE, THE IV SET HAS FILTER INSTALLED AT THE END OF LINE BEFORE THE ADAPTER RUBBER. AS THE FILTER SIZE IS 75 (200 MESH), THERE IS LITTLE POSSIBILITY THAT FOREIGN MATTER CAN FLOW INTO HUMAN BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV SET AN115 23G 1IN BP EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS WHITE FOREIGN MATERIAL IN THE IV SET TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV SET AN115 23G 1IN BP EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS WHITE FOREIGN MATERIAL IN THE IV SET TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483526 IV SET AN115 23G 1IN BP IV ADMINISTRATION SET FPA BECTON DICKINSON 2912231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other