BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 15802393 · Received November 15, 2022

    Report

    Report Number
    1710034-2022-00704
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 21, 2022
    Report Date
    January 23, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 18-NOV-2022. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 20GA X 1.16 INSYTE AUTOGUARD UNIT FROM LOT NUMBER 1152369. ADDITIONALLY, ONE PHOTO WAS PROVIDED. THROUGH THE VISUAL INSPECTION BLACK FOREIGN MATTER WAS OBSERVED IN THE SEAL OF THE PACKAGING AND ON THE CATHETER. THE UNIT WAS SENT FOR FURTHER MATERIAL ANALYSIS WHICH REVEALED LUBRICANT TO BE THE CLOSEST MATCH. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED, AND THE CAUSE APPEARED TO BE ATTRIBUTABLE TO THE PACKAGING PROCESS DURING MANUFACTURING AS A RESULT OF ENVIRONMENTAL FACTORS, INCOMING MATERIAL, OR PERSONNEL. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD PNK 20GA X 1.16IN FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD PNK 20GA X 1.16IN FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352538 BD INSYTE AUTOGUARD PNK 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 1152369 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown