BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9598498 · Received January 16, 2020

    Report

    Report Number
    1710034-2020-00012
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 26, 2019
    Report Date
    March 6, 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
    MI, 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 INCOMPLETE 18GA INSYTE AUTOGUARD IV CATHETER UNIT WITHIN AN OPENED PACKAGE FROM LOT NUMBER 9212028, REFERENCE NUMBER 381444. THE UNIT CONSISTED OF THE CATHETER TUBING WITH THE WEDGE INSIDE AND A GREEN ADAPTER. THERE WERE SOME TRACES OF DRIED MEDIA PRESENT INSIDE THE END OF THE ADAPTER AND ON THE CATHETER TUBING. THROUGH THE INVESTIGATION, WE DETERMINED THAT THIS TYPE OF FAILURE MODE COULD POTENTIALLY BE CAUSED BY INCORRECT SWEDGE DEPTH OR INCORRECT FLARE LENGTH. MEASUREMENT OF THE SWEDGE DEPTH COULD NOT BE PERFORMED SINCE THE WEDGE-TUBING ASSEMBLY WAS SEPARATED FROM THE ADAPTER. THE FLARE LENGTH WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. 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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE USING A BD INSYTE AUTOGAURD FOR AN IV INSERTION ON A PATIENT GETTING PREPPED FOR SURGERY, THE DEVICE MALFUNCTIONED CAUSING NO PAIN TO THE PATIENT BUT THE NEED TO REMOVE IV AND START A NEW SITE. THE DEVICE WAS DEFECTIVE IN THAT THE PLASTIC CATHETER TIP SEPARATED FROM THE HUB. THIS WAS CONCERNING TO ME AS THE SMALL PLASTIC PIECE IS SOMETHING THAT COULD HAVE ENTERED IN TO THE PATIENT AND BEEN A VERY DIFFICULT THING TO RETRIEVE OR COULD HAVE CAUSED GREAT HARM."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE USING A BD INSYTE AUTOGAURD FOR AN IV INSERTION ON A PATIENT GETTING PREPPED FOR SURGERY, THE DEVICE MALFUNCTIONED CAUSING NO PAIN TO THE PATIENT BUT THE NEED TO REMOVE IV AND START A NEW SITE. THE DEVICE WAS DEFECTIVE IN THAT THE PLASTIC CATHETER TIP SEPARATED FROM THE HUB. THIS WAS CONCERNING TO ME AS THE SMALL PLASTIC PIECE IS SOMETHING THAT COULD HAVE ENTERED IN TO THE PATIENT AND BEEN A VERY DIFFICULT THING TO RETRIEVE OR COULD HAVE CAUSED GREAT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62513 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381444 9212028 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other