BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 14893510 · Received July 1, 2022

    Report

    Report Number
    1710034-2022-00338
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 3, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED 12 SEALED AND 1 UNSEALED 24 GA X 0.75 IN INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 2053107. ADDITIONALLY, 3 PHOTOS WERE PROVIDED. A LEAK TEST WAS PERFORMED, AND ALL 12 SEALED UNITS PASSED TESTING. THE UNSEALED UNIT FAILED THE LEAK TEST. A MICROSCOPIC ANALYSIS WAS DONE TO FURTHER INVESTIGATE, AND IT WAS DISCOVERED THAT THERE WAS A V SHAPE CUT IN THE CATHETER WHICH INDICATES A DEFECT OF NEEDLE THROUGH CATHETER. THE REPORTED ISSUE WAS CONFIRMED AS THE NEEDLE PIERCED THROUGH THE CATHETER WALL. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. THIS DEFECT MAY ORIGINATE DURING THE MANUFACTURING PROCESS DUE TO ALIGNMENT OF THE SET TOGETHER STATION, BENT TUBING, OR AIR BLOW INCONSISTENCY. THERE IS A 100% VISION SYSTEM INSPECTION AND A SAMPLING PLAN IMPLEMENTED FOR LIE DISTANCE, WHICH MITIGATES THE OCCURRENCE OF THIS DEFECT. THIS DEFECT IS ALSO COMMON DURING TIP ADHESION BREAK DURING USE BY THE END USER. 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 THAT WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER MULTIPLE CATHETERS SPLINTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE REACHED OUT STATING THAT THEY ARE EXPERIENCING AN ISSUE WITH THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS. THE NURSE MENTIONED THAT THERE HAVE BEEN MULTIPLE INSTANCES WHERE THE INSTRUMENT IS SPLINTERED. ON (B)(6) 22 THIS ISSUE ALSO OCCURRED WHEN REMOVING FROM A PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER MULTIPLE CATHETERS SPLINTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE REACHED OUT STATING THAT THEY ARE EXPERIENCING AN ISSUE WITH THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS. THE NURSE MENTIONED THAT THERE HAVE BEEN MULTIPLE INSTANCES WHERE THE INSTRUMENT IS SPLINTERED. ON 6/3/22 THIS ISSUE ALSO OCCURRED WHEN REMOVING FROM A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280056 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER CATHETER, INTRAVASCULAR FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382512 2053107 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown