BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 11995885 · Received June 14, 2021

    Report

    Report Number
    1710034-2021-00491
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE DHR FOR LOT 0063779 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE DHR FOR LOT 0350087 HAS BEEN REVIEWED. NO RELATED PROCESS DEVIATIONS WERE FOUND. ONE POTENTIALLY RELATED QN WAS FOUND. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED LEAKAGE (BLOOD) THROUGH THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382523. BATCH NO.: 0063779. BLOOD CONTROL OF IAGBC ISN'T FUNCTIONAL, VALVE DOESN'T CLOSE, SO THE BLOOD COMES OUT WHEN THEY REMOVE THE NEEDLE.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0063779, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0350087, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED LEAKAGE (BLOOD) THROUGH THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382523, BATCH NO.: 0063779. BLOOD CONTROL OF IAGBC ISN'T FUNCTIONAL, VALVE DOESN'T CLOSE, SO THE BLOOD COMES OUT WHEN THEY REMOVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886523 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 SEE H10 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1