BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 16200338 · Received January 18, 2023

    Report

    Report Number
    1710034-2023-00013
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    December 28, 2022
    Report Date
    February 28, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 23-JAN-2023 INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE RETRACTED NEEDLE ASSEMBLY AND ONE OPENED 22G X 1.00IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 2243842. ADDITIONALLY, ONE PHOTOGRAPH WAS PROVIDED FOR INVESTIGATION. A GROSS VISUAL INSPECTION OF THE RETURNED UNITS DID NOT IDENTIFY ANY DAMAGE/DEFECTS TO THE COMPONENTS. BOTH UNITS WERE TESTED FOR NEEDLE RETRACTION AND FOUND TO SUCCESSFULLY RETRACT WITHOUT ISSUE. THE ALREADY RETRACTED UNIT WAS FURTHER INSPECTED MICROSCOPICALLY TO CHECK FOR ANY EVIDENCE THAT COULD HAVE PREVIOUSLY PREVENTED RETRACTION. NO ADHESIVE OR OTHER DAMAGE/DEFECTS COULD BE IDENTIFIED. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. ALTHOUGH THE REPORTED ISSUE WAS NOT CONFIRMED, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE. CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DID NOT RETRACT WHEN THE SAFETY BUTTON WAS PRESSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECENTLY HAD A LOT OF CONCERNS ABOUT THIS PRODUCT BELOW. BD INSYTE AUTOGUARD 22 GA X 1.00 IN. OUR IV THERAPISTS ARE STATING THE NEEDLE DOES NOT RETRACT WHEN THE SAFETY BUTTON IS PUSHED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DID NOT RETRACT WHEN THE SAFETY BUTTON WAS PRESSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECENTLY HAD A LOT OF CONCERNS ABOUT THIS PRODUCT BELOW. BD INSYTE AUTOGUARD 22 GA X 1.00 IN. OUR IV THERAPISTS ARE STATING THE NEEDLE DOES NOT RETRACT WHEN THE SAFETY BUTTON IS PUSHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394561 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2243842 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown