BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 19041251 · Received April 4, 2024

    Report

    Report Number
    1710034-2024-00283
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    October 12, 2023
    Report Date
    April 4, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810444
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SECOND EVENT DATE WAS CONFIRMED ON 29 MAR REQUIRING THIS ADDITIONAL MDR. OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED THREE UNSEALED 18GA X 1.16IN. INSYTE AUTOGUARD BC PRO UNITS FROM LOT NUMBER 2171961. ALL 3 UNSEALED UNITS WERE PROVIDED USED AND RETRACTED. THERE WAS NO DAMAGE OR DRY ADHESIVE DISCOVERED THAT MAY HAVE PREVENTED THE BUTTON FROM ACTIVATING. A FUNCTIONAL TEST AND MICROSCOPIC EXAMINATION REVEALED NO DAMAGE OR DEFECTS THAT COULD CONTRIBUTE TO THE REPORTED CAUSE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTIFY THE ROOT CAUSE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT RESULTING IN BLOOD TO FLOW PAST BLOOD CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE SAFETY ACTIVATION BUTTON HAD DIFFICULTY ENGAGING, THE IADE WITHDREW THE NEEDLE MANUALLY AND THEN BLOOD FLOWED AT THE CATHETER HUB, THE BLOOD CONTROL VALVE DID NOT STOP THE BLOOD REFLUX. YOU WILL FIND THE ANSWERS TO YOUR QUESTIONS INSERTED IN THE TEXT. - HAS THERE BEEN ANY IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, NECESSARY CHANGE IN TREATMENT)? I DON'T KNOW - WERE HEALTHCARE STAFF EXPOSED TO BLOOD OR BODY FLUIDS? YES CAN YOU CONFIRM WHETHER THE EVENTS CONCERNING THE TWO TIMES OCCURRED ON THE SAME DAY OR ON DIFFERENT DATES? IF THE DATES ARE DIFFERENT, PLEASE PROVIDE BOTH DATES. THE EVENTS OCCURRED ON TWO SEPARATE DATES, (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57685 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2171961 00382903810444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown