BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IV SET BN306 W/O BP 200C

    MDR report key: 12824380 · Received November 16, 2021

    Report

    Report Number
    2243072-2021-02729
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 19, 2021
    Report Date
    December 4, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-10-28. INVESTIGATION SUMMARY: 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. A SAMPLE WAS PROVIDED BY THE FACILITY FOR EVALUATION. BD INVESTIGATORS NOTED THAT THE PRESENCE OF A FOREIGN BODY IN THE TUBING OF THE DEVICE. THE ISSUE HAS BEEN CONFIRMED. COMPOSITIONAL TESTING OF THE FOREIGN BODY WAS ABLE TO IDENTIFY THE MATERIAL AS POLYESTER, WHICH IS THE PRIMARY COMPONENT OF THE TUBING. BASED ON THESE RESULTS OUR ENGINEERS HAVE DETERMINED THAT THE ROOT CAUSE FOR THIS EVENT IS RELATED TO THE EXTRUDING PROCESS. AN ABNORMALITY IN THE PROCESS LIKELY LEAD TO A SMALL PORTION OF THE RAW MATERIAL BECOMING OVERHEATED AND FORMING THE OBSERVED FOREIGN BODY. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD IV SET BN306 W/O BP 200C THERE WAS FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "FOREIGN MATTER IN IV SET TUBE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD IV SET BN306 W/O BP 200C THERE WAS FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "FOREIGN MATTER IN IV SET TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716935 BD IV SET BN306 W/O BP 200C INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown