BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10365492 · Received August 4, 2020

    Report

    Report Number
    1710034-2020-00495
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 13, 2020
    Report Date
    September 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 2020-08-13. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED THREE UNUSED INSYTE AUTOGURAD BC 22GA UNITS IN SEALED PACKAGES FROM MATERIAL NUMBER 381023, LOT NUMBER 9241830. IN ADDITION, SEVEN PHOTOGRAPHS WERE SUBMITTED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNITS. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED SAMPLES. TWO OF THE SAMPLES DISPLAYED PACKAGING TRIM INSIDE OF THE SEALED PACKAGES AND ONE ON THE OUT OF THE PACKAGE. THE OTHER PACKAGE DISPLAYED BLACK SUBSTANCE ON THE NEEDLE COVER. A BLACK FOREIGN MATTER WAS OBSERVED WITH THE THIRD UNIT. THIS UNIT REQUIRED SPECTRAL ANALYSIS TESTING. THE FOREIGN MATTER COULD NOT BE DEFINED. THE REPORTED ISSUE WAS CONFIRMED. THE TWO UNITS WITH THE PACKAGING TRIM OBSERVED IN THE SEAL CONFIRMS THIS DEFECT RESULTED FROM THE MANUFACTURING PROCESS. SINCE THE THIRD UNIT WAS RETURNED IN A SEALED PACKAGE, THE ROOT CAUSE OF THE BLACK FOREIGN FOUND ON THE NEEDLE COVER IS MOST LIKELY LINKED TO THE MANUFACTURING PROCESS AS WELL. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 3 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER FOREIGN MATTER WAS DISCOVERED ON CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DURING CHECKING AT SPD, BLACK SPOTS (FM) WERE FOUND ONTO 3 CATHETERS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH 3 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER FOREIGN MATTER WAS DISCOVERED ON CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING CHECKING AT SPD, BLACK SPOTS (FM) WERE FOUND ONTO 3 CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827810 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9241830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other