BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD INSYTE AUTOGUARD¿ BC PRO WINGED SHIELDED IV CATHETER

    MDR report key: 17398764 · Received July 26, 2023

    Report

    Report Number
    1710034-2023-00829
    Event Type
    Death
    Date Received
    July 26, 2023
    Date of Event
    June 29, 2023
    Report Date
    August 4, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903925124
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.2 DATE OF DEATH: THE DATE OF DEATH WAS NOT ABLE TO BE OBTAINED, THEREFORE, THE EVENT DATE WAS USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INSYTE AUTOGUARD¿ BC PRO WINGED SHIELDED IV CATHETER THE CATHETER BENT PIERCING OR SNAPPING THE VEIN. REPORTED THAT DEATH OCCURRED, EVENTS REGARDING THE PATIENTS DEATH, AND HOW IT WAS RELATED TO OUR DEVICE HAS NOT BEEN OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: MANAGEMENT OF A 25-MONTH-OLD CHILD WITH HYPERTHERMIA AND ASTHENIA+++. WE OBSERVE A RAPID DETERIORATION OF THE PATIENT, NECESSITATING THE INSERTION OF A VENOUS CATHETER. FOR THIS, WE USE THE EQUIPMENT MADE AVAILABLE TO US BY THE PHARMACY. THE BD INSYTE AUTOGUARD BC PRO 24G CATHETER IS DIFFICULT TO HANDLE. ONCE THE VEIN HAS BEEN PUNCTURED, THE CATHETER BENDS AT 45°, PIERCING OR SNAPPING THE VEIN. IF YOU MANAGE TO INSERT THE CATHETER, YOU HAVE TO KEEP IT PRESSED DOWN TO INJECT THE THERAPIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INSYTE AUTOGUARD¿ BC PRO WINGED SHIELDED IV CATHETER THE CATHETER BENT PIERCING OR SNAPPING THE VEIN. REPORTED THAT DEATH OCCURRED, EVENTS REGARDING THE PATIENTS DEATH, AND HOW IT WAS RELATED TO OUR DEVICE HAS NOT BEEN OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: MANAGEMENT OF A 25-MONTH-OLD CHILD WITH HYPERTHERMIA AND ASTHENIA. WE OBSERVE A RAPID DETERIORATION OF THE PATIENT, NECESSITATING THE INSERTION OF A VENOUS CATHETER. FOR THIS, WE USE THE EQUIPMENT MADE AVAILABLE TO US BY THE PHARMACY. THE BD INSYTE AUTOGUARD BC PRO 24G CATHETER IS DIFFICULT TO HANDLE. ONCE THE VEIN HAS BEEN PUNCTURED, THE CATHETER BENDS AT 45°, PIERCING OR SNAPPING THE VEIN. IF YOU MANAGE TO INSERT THE CATHETER, YOU HAVE TO KEEP IT PRESSED DOWN TO INJECT THE THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660404 BD INSYTE AUTOGUARD¿ BC PRO WINGED SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903925124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death