BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    MDR report key: 16317095 · Received February 7, 2023

    Report

    Report Number
    1710034-2023-00076
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 7, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 15-MAR-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED ONE CATHETER FROM AN 18GA X 1.16IN. INSYTE AUTOGUARD BC UNIT. A LEAK TEST WAS PERFORMED, AND NO LEAK WAS DETECTED. THE UNIT WAS THEN FLUSHED AND MICROSCOPICALLY ANALYZED BUT NO DAMAGE OR LEAK WAS DETECTED. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT AS NO DEFECT WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE LOT NUMBERS PROVIDED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2087312, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025, DEVICE MANUFACTURE DATE: 31-MAR-2022. MEDICAL DEVICE LOT #: 1322454, MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024, DEVICE MANUFACTURE DATE: 24-NOV-2021. MEDICAL DEVICE LOT #: 2182201, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025, DEVICE MANUFACTURE DATE: 14-JUL-2022. 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 · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY AND HUB JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE MATERNITY DEPARTMENT REPORTS A LEAK BETWEEN THE CATHETER AND THE PLASTIC WINGED PART REF. (B)(4). THE PROBLEM IS APPARENTLY RECURRENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY AND HUB JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE MATERNITY DEPARTMENT REPORTS A LEAK BETWEEN THE CATHETER AND THE PLASTIC WINGED PART REF. (B)(4). THE PROBLEM IS APPARENTLY RECURRENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229414 BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown