BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 8356167 · Received February 20, 2019

    Report

    Report Number
    2243072-2019-00294
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 25, 2019
    Report Date
    March 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    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 UNKNOWN. VISUAL INSPECTION OF RECEIVED SAMPLE: SBDM CONDUCTED VISUAL INSPECTION, FOUND THAT THE INNER WALL OF THE AIR VENT SEEMS TO BE IN A DAMAGED CONDITION. INVESTIGATION BY FILLING MEDICINE INTO THE AN120 COMPLAINT SAMPLE: SBDM FILLED MEDICINE INTO THE SPIKE AND CHAMBER UNDER NORMAL CONDITION, NO LEAKAGE WAS OBSERVED. INVESTIGATION BY FILLING MEDICINE INTO THE AN120 UNDER HIGH PRESSURE FOR COMPLAINT SAMPLE: SBDM FILLED MEDICINE INTO THE SPIKE & CHAMBER UNDER HIGH PRESSURE, LEAKAGE IN THE AN120 SPIKE AIR VENT OCCUR WHEN THE AIR PRESSURE WAS OVER 0.22 MPA. HOUSE SAMPLE LEAKAGE TEST: SBDM CONDUCTED HIGH PRESSURE LEAKAGE TEST OF OVER 0.50 MPA, 5 PCS EACH LOT (2812071, 2812131, 2812151, 2812201 & 2812221), NO LEAKAGE WAS OBSERVED. DEVICE HISOTRY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2812071, 2812131, 2812151, 2812201 & 2812221, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT RECORD FOR LOT 2812071, 2812131, 2812151, 2812201 & 2812221, THERE ARE NO SAME ISSUE FROM OTHER CUSTOMERS. ROOT CAUSE: SBDM INSPECTED THE COMPLAINT SAMPLE & HOUSE SAMPLES, FOUND THAT THERE WAS NO LEAKAGE WHEN THE INFUSION SET WAS PLUMBING. THERE WAS NO LEAKAGE UNDER NORMAL USING CONDITION BUT, IF THE PRESSURE WAS OVER 0.22 MPA SBDM COULD FIND LEAKAGE ON THE AIR VENT OF SPIKE. SBDM THEN CONDUCT VISUAL INSPECTION OF THE COMPLAINT SAMPLE AND IT SEEMS THAT INNER WALL OF AIR VENT HAD DAMAGED. THE LIKELY CAUSE IS ASSUMED TO BE TEMPORARY MALFUNCTION OF AIR FILTER ASSEMBLY MACHINE DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A IV SET AN120 W/O BP HAD LEAKAGE FROM THE AIR VENT.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 FROM THE AIR VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149375 IV SET AN120 W/O BP INFUSION SET LHI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other