BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INFUSION DEVICE PRESSURE RESISTANT, LL

    MDR report key: 16959523 · Received May 19, 2023

    Report

    Report Number
    9616066-2023-00962
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 27, 2023
    Report Date
    June 7, 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

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE LOT #: 220220611 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A 03500110109HN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER THE CUSTOMER INDICATES THAT THE CAP OF THE LUER WAS FOUND TO HAVE BEEN DISCONNECTED WITHIN THE PACKAGING. 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 220220611 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER AS A RESULT OF PREVIOUS SIMILAR FEEDBACK, THE MANUFACTURING SITE HAVE RETRAINED THE MANUFACTURING OPERATORS TO ENSURE THAT SUFFICIENT FORCE IS APPLIED DURING THE MANUAL ASSEMBLY OF THIS COMPONENT, WHICH SHOULD REDUCE THE LIKELIHOOD OF REPORTS OF THIS NATURE IN FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INFUSION DEVICE PRESSURE RESISTANT, LL THE SPIKE CAP CAME OFF BEFORE USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAP COMES OFF BEFORE THE PRODUCT IS UNPACKED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INFUSION DEVICE PRESSURE RESISTANT, LL THE SPIKE CAP CAME OFF BEFORE USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAP COMES OFF BEFORE THE PRODUCT IS UNPACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853382 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