BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9721736 · Received February 18, 2020

    Report

    Report Number
    1710034-2020-00095
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 15, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED INSYTE AUTOGUARD BC 18GA ADAPTER AND A CATHETER/WEDGE ASSEMBLY WITH AN OPENED EMPTY PACKAGE FROM MATERIAL NUMBER 381444, LOT NUMBER 9193575. IN ADDITION, THREE PHOTOGRAPHS WERE SUBMITTED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. A VISUAL/MICROSCOPIC EVALUATION OF THE RETURNED SAMPLE REVEALED THE WEDGE/TUBING TO BE SEPARATED FROM THE ADAPTER. THE REPORTED ISSUE WAS CONFIRMED. THIS TYPE OF FAILURE IS LIKELY TO BE A MANUFACTURING PROCESS RELATED ISSUE. THE FAILURE MODE OF ¿CATHETER WEDGE BACK OUT¿ COULD POTENTIALLY BE CAUSED BY INCORRECT SWAGE DEPTH OR INCORRECT FLARE LENGTH. MEASUREMENT OF THE SWAGE DEPTH COULD NOT BE PERFORMED SINCE THE WEDGE-TUBING ASSEMBLY WAS SEPARATED FROM THE ADAPTER. MEASUREMENTS OF THE WEDGE DIMENSION WERE PERFORMED TO VERIFY THE WEDGE BASE WAS WITHIN SPECIFICATIONS AND WOULD NOT BE ¿LOOSE¿ WITHIN THE ADAPTER. THIS MEASUREMENT WAS FOUND ACCEPTABLE PER SPECIFICATION. THE ADAPTER DIAMETER AND FLARE LENGTH WERE ALSO MEASURED WITHIN SPECIFICATIONS. FURTHER INSPECTION OF THE ADAPTER CONFIRMED THE SWAGING PROCESS WAS NOT COMPLETED. THIS TYPE OF DEFECT IS UNLIKELY TO OCCUR BY THE END USER. THE EVIDENCE PROVIDED CONFIRMS THIS TO BE A MANUFACTURING PROCESS ISSUE. CAPA#1461582 WAS INITIATED. DHR FOR LOT NUMBER 9193575 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER ADAPTER SEPARATED FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381444 BATCH NO.: 9193575. IT WAS REPORTED THAT THE PLASTIC LUER-LOCK ADAPTER SEPARATED FROM THE CATHETER PORTION OF THE DEVICE. THE PLASTIC LUER LOCK HUB SEPARATED FROM THE IV CATHETER ITSELF WHILE IN THE PATIENT.  FLUID WENT ALL OVER THE PLACE, BUT NO HARM WAS DONE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER ADAPTER SEPARATED FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381444, BATCH NO.: 9193575. IT WAS REPORTED THAT THE PLASTIC LUER-LOCK ADAPTER SEPARATED FROM THE CATHETER PORTION OF THE DEVICE. THE PLASTIC LUER LOCK HUB SEPARATED FROM THE IV CATHETER ITSELF WHILE IN THE PATIENT.  FLUID WENT ALL OVER THE PLACE, BUT NO HARM WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187670 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381444 9193575 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other