BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8734553 · Received June 26, 2019

    Report

    Report Number
    1710034-2019-00675
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 6, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. MEDICAL DEVICE TYPE: FOZ.. COMMON DEVICE NAME: INTRAVASCULAR CATHETER.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 20 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 8278838 AND PHOTOS OF THE DEFECT 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 SIGNS OF FOREIGN MATTER ON THE NEEDLE COVER OR ADAPTER ASSEMBLY. HOWEVER, AFTER REVIEWING THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO SEE A PIECE OF BLACK THREAD ON THE TIP OF THE CATHETER TUBING. BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, SINCE THERE WAS NO FOREIGN MATTER ON THE RETURNED UNIT AND DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FM LIKE FRAGMET OF PLASTIC WAS ON THE CATHETER TIP."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FM LIKE FRAGMET OF PLASTIC WAS ON THE CATHETER TIP."

    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 FOREIGN MATTER OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "FM LIKE FRAGMET OF PLASTIC WAS ON THE CATHETER TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531334 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8278838

    Patients

    Seq Age Sex Outcome Treatment
    1 Other