BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 8471239 · Received April 1, 2019

    Report

    Report Number
    2243072-2019-00624
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 26, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FRN
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2901021. VISUAL INSPECTION OF COMPLAINT SAMPLE: SBDM CONDUCT VISUAL INSPECTION OF COMPLAINT SAMPLE, THE INNER WALL OF THE AIR VENT LOOK DAMAGED. INVESTIGATION BY FILLING MEDICINE INTO THE AN120: SBDM FILL MEDICINE INTO THE SPIKE & CHAMBER UNDER NORMAL CONDITION, THEY COULD NOT FIND LEAKAGE IN THE SPIKE AIR VENT. INVESTIGATION BY FILLING MEDICINE INTO THE AN120 UNDER HIGH PRESSURE: SBDM FILL MEDICINE INTO THE SPIKE & CHAMBER UNDER HIGH PRESSURE, THEY FOUND LEAKAGE IN THE SPIKE AIR VENT WHEN THE AIR PRESSURE WAS OVER 0.23 MPA. HOUSE SAMPLE INSPECTION: SBDM INSPECTED THE 5 PCS EACH FROM LOTS (NO 2812201, 2812221, 2901021, 2901072 & 2901081) FROM THE HOUSE SAMPLES, NO LEAKAGE IS OBSERVED EVEN AS THE AIR PRESSURE WAS OVER 0.52 MPA. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED MANUFACTURING RECORD FOR 2901021, NO ABNORMALITY WAS OBSERVED. ROOT CAUSE: SBDM CONDUCT VISUAL INSPECTION OF THE COMPLAINT SAMPLE AND FOUND THE INNER WALL OF AIR VENT HAD DAMAGED. SBDM FOUND THERE WAS NO LEAKAGE UNDER NORMAL USING CONDITION BUT, IF THE PRESSURE WAS OVER 0.23 MPA LEAKAGE ON THE AIR VENT OF SPIKE COULD BE OBSERVED. THE LIKELY CAUSE IS DURING ULTRASONIC ASSEMBLY PROCESS OF CHAMBER + SPIKE + AIR FILTER. THERE IS A JIG WHICH IS TO ALIGN SPIKE AIR VENT HOLE TO ASSEMBLE AIR FILTER. HOWEVER, IF THE CENTER OF THE JIG IS NOT MATCHED WITH THE CENTER OF SPIKE, THE INNER WALL OF SPIKE COULD BE DAMAGED AND THE AIR FILTER IN TURN, COULD BE DAMAGED TOO. SBDM CONCLUDED THAT TEMPORARY MALFUNCTION OF AIR FILTER ASSEMBLY MACHINE CAUSES THIS COMPLAINT CASE. SBDM HAS IN HOUSE CAPA-19-018 IN PLACE TO MONITOR DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A IV SET AN120 W/O BP HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "AIRVENT LEAKAGE. AS SOON AS THE IV SET IS CONNECTED TO THE FLUID, THE FLUID FLOWS INTO THE AIR VENT."

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A IV SET AN120 W/O BP HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "AIRVENT LEAKAGE. AS SOON AS THE IV SET IS CONNECTED TO THE FLUID, THE FLUID FLOWS INTO THE AIR VENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265127 IV SET AN120 W/O BP INFUSION SET FRN BECTON DICKINSON 2901021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other