BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10457687 · Received August 26, 2020

    Report

    Report Number
    1710034-2020-00537
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 6, 2020
    Report Date
    October 12, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 8/27/2020. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 22GA INSYTE AUTOGUARD WINGED CATHETER/ADAPTOR ASSEMBLY AND AN OPENED EMPTY PACKAGE FROM MATERIAL NUMBER 381923, LOT NUMBER 9231262. IN ADDITION, TWO PHOTOGRAPHS WERE RECEIVED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. A VISUAL/MICROSCOPIC EVALUATION WAS PERFORMED ON THE RETURNED SAMPLE WHICH DISPLAYED DAMAGE TO THE THREADS ON THE OUTSIDE OF THE LUER END OF THE ADAPTER. A FUNCTIONAL ASSESSMENT OF THE CONNECTION COMPATIBILITY OF THE RETURNED CATHETER/ADAPTOR ASSEMBLY WAS CONDUCTED TO EVALUATE THIS REPORTED INCIDENT. THE DAMAGE TO THE OUTER THREADS OF THE LUER ADAPTER PREVENTED A SUCCESSFUL CONNECTION BETWEEN THE ADAPTER AND A LAB SUPPLIED EXTENSION TUBING SET. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A PROBABLE MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO GRIPPER OR ADAPTER MISALIGNMENT DURING THE BUILD OF THIS UNIT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT WOULD NOT CONNECT TO THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "IMPOSSIBLE TO SCREW THE STENT INTO THE CATHETER. SAME PROBLEM WITH A SECOND STENT. THE PROBLEM SEEMS TO COME FROM THE CATHETER WHICH HAS A DEFECT ON THE THREAD. THE PATIENT HAD TO BE REINFUSED WITH ANOTHER CATHETER. THE PATIENT WHO WAS HARD TO PUNCTURE HAD TO BE REPERFUSED. CATHETER CHANGE AND FAULTY DM SET ASIDE."

    Additional Manufacturer Narrative · 1

    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 THE STENT WOULD NOT CONNECT TO THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IMPOSSIBLE TO SCREW THE STENT INTO THE CATHETER. SAME PROBLEM WITH A SECOND STENT. THE PROBLEM SEEMS TO COME FROM THE CATHETER WHICH HAS A DEFECT ON THE THREAD. THE PATIENT HAD TO BE REINFUSED WITH ANOTHER CATHETER. THE PATIENT WHO WAS HARD TO PUNCTURE HAD TO BE REPERFUSED. CATHETER CHANGE AND FAULTY DM SET ASIDE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922260 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9231262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other