BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ GP SERIES ONCOLOGY LIGHT-RESISTANT PRIMARY SET

    MDR report key: 16992814 · Received May 24, 2023

    Report

    Report Number
    2243072-2023-00875
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    May 2, 2023
    Report Date
    June 12, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS CAZIN, BOSNIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 23-MAY-2023. H6: INVESTIGATION SUMMARY : ONE 60643 SAMPLE FROM LOT 1020271 WAS RECEIVED FOR INVESTIGATION IN WHICH THE CUSTOMER HAS REPORTED FINDING A "CONTAMINANT INSIDE THE DRIP CHAMBER." THE SAMPLE WAS RECEIVED WITH OPENED PACKAGING AND WITH RESIDUAL FLUID PRESENT THROUGHOUT. EXAMINATION OF THE SAMPLE CONFIRMED THE CUSTOMER'S EXPERIENCE, AS MULTIPLE SMALL SPOTS WERE NOTED ON THE DRIP CHAMBER WALL. UPON CLOSER INSPECTION THE SPOTS WERE FOUND TO BE EMBEDDED IN THE WALL OF THE DRIP CHAMBER COMPONENT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. PREVIOUS INVESTIGATIONS HAVE FOUND THAT SUCH CONTAMINATION IS LIKELY TO HAVE BEEN CAUSED BY BURNT GRANULES FROM THE RAW MATERIAL THAT HAVE BEEN EMBEDDED INTO THE DRIP CHAMBER WALL DURING THE INJECTION MOLDING PROCESS. THIS IS A COSMETIC DEFECT ONLY AND DOES NOT AFFECT THE FUNCTIONALITY OR STERILITY OF THE PRODUCT. A REVIEW OF THE PRODUCTION RECORDS FOR 1020271 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THE REPORTED FEEDBACK DURING FUTURE PRODUCTION OF THIS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN CONTAMINANT WAS FOUND INSIDE THE BD ALARIS¿ GP SERIES ONCOLOGY LIGHT-RESISTANT PRIMARY SET SET DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINANT INSIDE THE DRIP CHAMBER".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN CONTAMINANT WAS FOUND INSIDE THE BD ALARIS¿ GP SERIES ONCOLOGY LIGHT-RESISTANT PRIMARY SET DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINANT INSIDE THE DRIP CHAMBER"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970737 BD ALARIS¿ GP SERIES ONCOLOGY LIGHT-RESISTANT PRIMARY SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 1020271

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown