BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES

    MDR report key: 16740496 · Received April 13, 2023

    Report

    Report Number
    9616066-2023-00684
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 24, 2023
    Report Date
    June 22, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES,. D10: RETURNED TO MANUFACTURER ON: 08-MAY-2023. H6: INVESTIGATION SUMMARY: SAMPLE AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, BROWN PARTICLE OBSERVED TO BE EMBEDDED ON THE SPIKE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111204, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. 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 WHILE USING BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM DESCRIPTION: OPENED A SEALED PACKAGE AND NOTICED BROWN SPOTS ON THE PLASTIC - APPEARS DIRTY, AND NOT STERILE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM DESCRIPTION: OPENED A SEALED PACKAGE AND NOTICED BROWN SPOTS ON THE PLASTIC - APPEARS DIRTY, AND NOT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249435 BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES INTRAVASCULAR ADMINISTRATION SET ONB SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 515306 2111204 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown