BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES

    MDR report key: 15761336 · Received November 9, 2022

    Report

    Report Number
    3003152976-2022-00501
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 13, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 10-FEB-2023. H6: INVESTIGATION SUMMARY: TEN UNUSED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCTS WERE VISUALLY INSPECTED, THERE WAS NO DAMAGE OR OTHER DEFECTS OBSERVED ON ANY OF THE INFUSION ADAPTERS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2202222, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THAT THE PRODUCT IS FREE FROM DAMAGE AND ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. ALL RETURNED SAMPLES UNDERWENT THESE EVALUATIONS AND PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATION, INCLUDING PROPER SPIKE LENGTH AND DIAMETER. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AIR IN THE SYSTEM. WE HAVE HAD A BIG PROBLEM WITH THE NEW INFUSION SETS FROM IN COMBINATION WITH PHASEAL'S ADAPTER FOR ANTIBIOTIC MIXING THE LAST FEW DAYS. WHEN USING THESE TWO TOGETHER, THE ENTIRE DRIP CHAMBER FILLS WITH AIR AND SPREADS OUT INTO THE DRIP LINE. WE HAVE HAD NO PROBLEMS WITH AIR INTAKE WHEN THE UNIT IS USED ALONE FOR INFUSIONS. IT IS AN AUTOMATIC SELF-REGULATING VALVE ON THE UNITS THAT SHOULD ONLY BE OPEN FOR INFUSIONS FROM A GLASS BOTTLE. WE HAVE OF COURSE TRIED BOTH WITH THE VALVE OPEN AND CLOSED BUT WITH THE SAME RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AIR IN THE SYSTEM. WE HAVE HAD A BIG PROBLEM WITH THE NEW INFUSION SETS FROM IN COMBINATION WITH PHASEAL'S ADAPTER FOR ANTIBIOTIC MIXING THE LAST FEW DAYS. WHEN USING THESE TWO TOGETHER, THE ENTIRE DRIP CHAMBER FILLS WITH AIR AND SPREADS OUT INTO THE DRIP LINE. WE HAVE HAD NO PROBLEMS WITH AIR INTAKE WHEN THE UNIT IS USED ALONE FOR INFUSIONS. IT IS AN AUTOMATIC SELF-REGULATING VALVE ON THE UNITS THAT SHOULD ONLY BE OPEN FOR INFUSIONS FROM A GLASS BOTTLE. WE HAVE OF COURSE TRIED BOTH WITH THE VALVE OPEN AND CLOSED BUT WITH THE SAME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2952284 BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515306 2202222 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown