BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8656170 · Received May 30, 2019

    Report

    Report Number
    1710034-2019-00565
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 2, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED A 20GA INSYTE AUTOGUARD BC ASSEMBLY. THE NEEDLE WAS RECEIVED FULLY RETRACTED. ALONG WITH A NEEDLE COVER WITHIN AN OPEN PACKAGE FROM LOT NUMBER 8200662. THROUGH THE VISUAL/MICROSCOPIC EVALUATION OF THE OPENED UNIT A WHITE-CLEAR SPECK WAS FOUND ON THE PLASTIC BAG OF THE UNIT WAS RECEIVED. THE PHOTOGRAPHS DISPLAYED SIMILAR FINDINGS TO THAT OF THE RETURNED UNIT. THE WHITE-CLEAR MATERIAL OBSERVED NEAR THE CATHETER TUBING WAS CONFIRMED TO BE NON-FOREIGN (PLUG SHAVINGS) WHICH RESULTED FROM MANUFACTURING DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER TIP SHEARING OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "UPON OPENING THE IV CATHETER PACKAGING AND INSPECTING THE DEVICE, THE RN NOTED THE CATHETER TIP WAS SHEARED AND DID NOT PLACE."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER TIP SHEARING OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "UPON OPENING THE IV CATHETER PACKAGING AND INSPECTING THE DEVICE, THE RN NOTED THE CATHETER TIP WAS SHEARED AND DID NOT PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447306 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8310640 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other