BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 13480961 · Received February 8, 2022

    Report

    Report Number
    1710034-2022-00060
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    January 25, 2022
    Report Date
    February 22, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1230859; MEDICAL DEVICE EXPIRATION DATE: 2024-07-31; DEVICE MANUFACTURE DATE: 2021-08-18. MEDICAL DEVICE LOT #: 1172888; MEDICAL DEVICE EXPIRATION DATE: 2024-05-31; DEVICE MANUFACTURE DATE: 2021-06-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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 3 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETERS EACH FROM LOTS 1230859 AND 1172888 KINKED DURING USE AND SALINE COULD NOT BE ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CATHETER SEEMS TO GET KINKED WHEN PATIENT ARMED IS RAISED. UNABLE TO ADMINISTER ANY CONTRAST WITH SALINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EACH FROM LOTS 1230859 AND 1172888 KINKED DURING USE AND SALINE COULD NOT BE ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CATHETER SEEMS TO GET KINKED WHEN PATIENT ARMED IS RAISED. UNABLE TO ADMINISTER ANY CONTRAST WITH SALINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850906 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382512 SEE SECTION H10 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown