BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER

    MDR report key: 16989871 · Received May 23, 2023

    Report

    Report Number
    1710034-2023-00560
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 1, 2023
    Report Date
    July 10, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903926374
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 3010249; D4: MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026; H4: DEVICE MANUFACTURE DATE: 14-JAN-2023. D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 16-MAY-2023. H6: INVESTIGATION SUMMARY BD RECEIVED TWENTY EIGHT 20 GAUGE INSYTE AUTOGUARD BLOOD CONTROL WINGED UNITS FROM LOT 3010249 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED NO PHYSICAL DAMAGE OR DEFORMITIES. NEXT, THE UNITS WERE TESTED FOR LEAKAGE TO IDENTIFY ANY DAMAGE THAT COULD NOT BE IDENTIFIED BY THE NAKED EYE BUT NO LEAKS WERE FOUND. NO DAMAGE OR DEFECTS WERE FOUND TO THE RETURNED UNITS. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER SHEARED APART DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE RECEIVED TWO REPORTS OF DEFECTIVE IV CATHETERS- ONE FROM EMS PROVIDERS AND ONE FROM AN ED STAFF RN. IN BOTH INSTANCES, REPORT OF SHEARING OF THE IV CATHETER. NO PATIENT HARM NOTED IN EITHER EVENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER SHEARED APART DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE RECEIVED TWO REPORTS OF DEFECTIVE IV CATHETERS- ONE FROM EMS PROVIDERS AND ONE FROM AN ED STAFF RN. IN BOTH INSTANCES, REPORT OF SHEARING OF THE IV CATHETER. NO PATIENT HARM NOTED IN EITHER EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541673 BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 392637 3010249 00382903926374

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown