BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10900574 · Received November 25, 2020

    Report

    Report Number
    1710034-2020-00748
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 29, 2020
    Report Date
    January 21, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/17/2020. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE 20GA INSYTE AUTOGUARD BLOOD CONTROL IV CATHETER UNIT WITHIN AN UNDAMAGED OPENED PACKAGING FROM MATERIAL NUMBER 381033, LOT NUMBER 8243579. THE UNIT CONTAINED ALL COMPONENTS PRESENT. THROUGH THE VISUAL MICROSCOPIC EVALUATION, THE UNIT REVEALED A CLEAR BROWNISH FOREIGN MATTER NEAR THE TIP OF THE CATHETER AND STRANDS IN AREAS THROUGHOUT THE NEEDLE AND GRIP. THE NEEDLE WAS THEN PUSHED TO THE OUT POSITION. BOTH THE CATHETER AND NEEDLE TIPS WERE FOUND ACCEPTABLE PER SPECIFICATION. THERE WAS NO PHYSICAL MECHANICAL DAMAGE TO THE COMPONENTS. FURTHER SPECTRAL ANALYSIS WAS PERFORMED TO IDENTIFY THE FOREIGN MATTER. THE RESULTS STATED THE FOREIGN MATTER TO BE SILICONE WHICH IS EXPECTED TO BE FOUND ON THE CATHETER AND NOT CONSIDERED A FOREIGN MATTER. CELLULOSE AND LIGNIN WERE ALSO IDENTIFIED WHICH WOULD RELATE THIS TO OUR MANUFACTURING AREA AS A PART OF THE TERRY WIPERS THAT ARE USED FOR SURFACE CLEANING. THE REPORTED ISSUE OF THE CATHETER BEING DAMAGED WAS NOT CONFIRMED AS DAMAGE WAS NOT OBSERVED WITH THE UNIT. THE DEFECT WAS CONFIRMED AS FOREIGN MATTER ON THE DEVICE. 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¿ BC SHIELDED IV CATHETER EXPERIENCED DATHETER DAMAGE/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN IT CAME OUT OF ITS PLASTIC WRAPPING, THE CATHETER WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED CATHETER DAMAGE/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN IT CAME OUT OF ITS PLASTIC WRAPPING, THE CATHETER WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365244 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8243579

    Patients

    Seq Age Sex Outcome Treatment
    1