BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15492929 · Received September 27, 2022

    Report

    Report Number
    1710034-2022-00554
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2124170, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025, DEVICE MANUFACTURE DATE: 05-MAY-2022. MEDICAL DEVICE LOT #: 2053152, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025, DEVICE MANUFACTURE DATE: 22-FEB-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 13-SEP-2022 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 24GA X 0.75IN. INSYTE AUTOGUARD BC UNIT AND ONE PHOTOGRAPH. THROUGH THE VISUAL INSPECTION, THE UNIT DISPLAYED TRACES OF MEDIA AND A NEEDLE SPEAR THROUGH THE CATHETER. THE REPORTED ISSUE WAS CONFIRMED. AS THE DEVICE HAS BEEN REMOVED FROM THE PACKAGE AND HANDLED, IT IS LIKELY THAT THE DEFECT ORIGINATED IN THE USER ENVIRONMENT. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. DURING USE, A NEEDLE SPEAR THROUGH MAY OCCUR DURING TIP ADHESION BREAK OR DURING VENIPUNCTURE IF THE NEEDLE IS ADVANCED AT THE WRONG ANGLE OR IF THE NEEDLE IS MOVED UP AND DOWN THE CATHETER TUBING. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WHILE INTRODUCING IT. THIS EVENT OCCURRED EITHER IN LOT 2124170 OR 2053152. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF THE NURSES WAS ATTEMPTING TO PUT THIS IV IN A PATIENT. SHE GOT TO A POINT WHERE SHE COULD NOT ADVANCE IT AND HAD TO TAKE IT OUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WHILE INTRODUCING IT. THIS EVENT OCCURRED EITHER IN LOT 2124170 OR 2053152. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF THE NURSES WAS ATTEMPTING TO PUT THIS IV IN A PATIENT. SHE GOT TO A POINT WHERE SHE COULD NOT ADVANCE IT AND HAD TO TAKE IT OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076444 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H10 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown