BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 12344784 · Received August 19, 2021

    Report

    Report Number
    2243072-2021-02113
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 27, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 7/28/2021 H.6. INVESTIGATION: UNFORTUNATELY A LOT NUMBER COULD NOT BE SUBMITTED FOR THIS COMPLAINT, AND COULD NOT BE DETERMINED FROM THE PHOTOGRAPHS PROVIDED. PREVENTING OUR INVESTIGATION TEAM FROM CONDUCTING A DEVICE HISTORY REVIEW. ADDITIONALLY, THE SUBMITTED SAMPLE HAS BEEN REVIEWED BY OUR TEAM OF QUALITY ENGINEERS. THE RETURNED SAMPLE DISPLAYED SEPARATION BETWEEN THE CHAMBER AND THE SPIKE. BASED ON ANALYSIS OF THE MANUFACTURING LINE THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS LIKELY RELATED TO THE ADHESIVE APPLICATION PROCESS; A TEMPORARY MALFUNCTION IN THE MANUFACTURING LINE COULD RESULT IN A POOR CONNECTION OF THE CONSTITUENT PARTS. SBDM INSPECTED THE LOT NO. (LOT NO 2106222, 2107011 & 2107171) AS OF THE HOUSE SAMPLES, THERE WAS NO DISCONNECTED SPIKE AND CHAMBER. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV SET AN120 W/O BP SPIKE BROKE FROM THE CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE USER STARTED TO USE IV SET, THE SPIKE HAD BEEN DETACHED FROM THE CHAMBER"

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV SET AN120 W/O BP SPIKE BROKE FROM THE CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE USER STARTED TO USE IV SET, THE SPIKE HAD BEEN DETACHED FROM THE CHAMBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238908 IV SET AN120 W/O BP INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1