BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 12916302 · Received December 2, 2021

    Report

    Report Number
    9616066-2021-52525
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 3, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. BRAND NAME. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 THE PROVIDED POTENTIAL BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN WAS INVOLVED WITH A PATIENT EXPERIENCING INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CARDIOLOGY DEPARTMENT SAID THEY HAVE HAD AN UNUSUAL FREQUENCY OF LYMPHANGITIS FOR 15 DAYS-3 WEEKS WITH AROUND 30 PATIENTS. THERE HAVE BEEN NO CHANGES IN PRACTICES AND THE INCIDENTS ARE NOT LINKED TO TEAM TURNOVER. THERE WERE NO MEDICAL INTERVENTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN WAS INVOLVED WITH A PATIENT EXPERIENCING INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CARDIOLOGY DEPARTMENT SAID THEY HAVE HAD AN UNUSUAL FREQUENCY OF LYMPHANGITIS FOR 15 DAYS-3 WEEKS WITH AROUND 30 PATIENTS. THERE HAVE BEEN NO CHANGES IN PRACTICES AND THE INCIDENTS ARE NOT LINKED TO TEAM TURNOVER. THERE WERE NO MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813365 SEE H10 INTRAVASCULAR CATHETER FOZ SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other