BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 8568938 · Received May 1, 2019

    Report

    Report Number
    2243072-2019-00827
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 16, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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 2901242. SBDM NOTICED BLACK FM INSIDE THE TUBING. INFRARED SPECTROMETRY (IR) TEST: BASED ON IR TEST, THE FM IS DETERMINE TO BE SAME MATERIAL AS RAW MATERIAL OF TUBING. HOUSE SAMPLE INSPECTION: SBDM INSPECTED TOTAL 30 PCS FROM LOTS 2901222, 2901242 AND 2901252, NO ABNORMALITY OBSERVED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD, NO ABNORMALITY OBSERVED. ROOT CAUSE: FROM INVESTIGATION, THE LIKELY CAUSE IS THE TUBE COMPONENT IS EXTRUDED ON HIGH TEMPERATURE (145 165). SBDM CONCLUDED THAT PVC(RAW MATERIAL OF TUBE) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE AND IT WAS STUCK INTO THE COMPLAINT TUBE WHILE EXTRUDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE IV SET AN120 W/O BP THERE WAS BLACK FOREIGN MATERIAL IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL (BLACK)IN THE TUBE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE IV SET AN120 W/O BP THERE WAS BLACK FOREIGN MATERIAL IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL (BLACK) IN THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361216 IV SET AN120 W/O BP INFUSION SET FPA BECTON DICKINSON 2901242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other