BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 12329096 · Received August 16, 2021

    Report

    Report Number
    1710034-2021-00711
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 13, 2021
    Product Code
    FOZ
    UDI-DI
    30382903826125
    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: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND A CATHETER THAT SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER WITH BLOOD CONTROL, WINGED [382612] DEFECTIVE COMPONENT, DETACHMENT OF DEVICE OR DEVICE COMPONENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN. 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 THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND A CATHETER THAT SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD INSYTE AUTOGUARD SHIELDED I.V. CATHETER WITH BLOOD CONTROL, WINGED [382612] DEFECTIVE COMPONENT, DETACHMENT OF DEVICE OR DEVICE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222189 SEE H10 INTRAVASCULAR CATHETER FOZ 382612 UNKNOWN 30382903826125

    Patients

    Seq Age Sex Outcome Treatment
    1