BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INFUSION DEVICE PRESSURE RESISTANT, LL

    MDR report key: 17299442 · Received July 11, 2023

    Report

    Report Number
    9616066-2023-01403
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 24, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A 03500110109HN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT: 20220611. THE CUSTOMER HAS INDICATED THAT A CAP ON THE MALE LUER WAS MISSING WITHIN THE SEALED PACKAGING. AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF THE PHOTOGRAPH CONFIRMED THAT THE MALE LUER CAP WAS MISSING (APPENDICES 1 & 2). THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER, ANHUI TIANKANG MEDICAL PRODUCTS CO. LTD, FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT: 20220611 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THEY CONFIRMED THAT THIS IS A MANUAL ASSEMBLY STEP AND THEREFORE THE CUSTOMER'S EXPERIENCE IS LIKELY TO HAVE OCCURRED DUE TO HUMAN ERROR. IN ORDER TO REDUCE THE LIKELIHOOD OF OPERATOR ERROR, THE PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THIS FEEDBACK TO ENSURE THAT THEY ARE FOLLOWING THE CORRECT ASSEMBLY PROCESS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). MEDICAL DEVICE LOT #: 220220611 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INFUSION DEVICE PRESSURE RESISTANT, LL PRIME CAP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIME CAP WAS MISSING IN THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INFUSION DEVICE PRESSURE RESISTANT, LL PRIME CAP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: PRIME CAP WAS MISSING IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147663 BD INFUSION DEVICE PRESSURE RESISTANT, LL INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown