BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 18685525 · Received February 12, 2024

    Report

    Report Number
    1710034-2024-00093
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 22, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: A CODE UPDATED TO BETTER REFLECT THE DEFECT AS THE HOLE IN THE CATHETER LED TO THE LEAK. INVESTIGATION RESULTS: NO PHOTOGRAPHIC EVIDENCE OR PHYSICAL SAMPLES WERE ACCESSIBLE TO INVESTIGATE THE REPORTED CONDITION. OUR QUALITY ENGINEER TEAM CONDUCTED A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED MATERIAL NUMBER 382533 AND LOT NUMBER 3251082. THIS REVIEW DID NOT UNCOVER ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CAUSED THIS DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN THE SPECIFIED STANDARDS. UNFORTUNATELY, THE EXACT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. WE WILL CONTINUE TO TRACK AND ANALYZE COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION IN ORDER TO IDENTIFY ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E. ADDRESS REFLECTS FACILITY. FACILITY REPORTER NAME PROVIDED IS (B)(6). E. CONTACT PHONE NUMBER AND EMAIL IS THE DISTRIBUTOR.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC LEAKED AT CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: CUSTOMER (B)(6) TO REPORT THEIR CT TECH TOLD THEM THAT A BOX OF HAS A HOLD IN THEM THAT CAUSES THE SALINE FLUSH TO SPRAY OUT ONTO THE PATIENT. CUSTOMER SAID THIS HAS HAPPENED A FEW TIMES. REQUESTING REPLACEMENT. 6 FEB 2024 PLEASE FIND THE CUSTOMER¿S RESPONSE BELOW ¿ DATE OF EVENT: UNKNOWN- HAPPENED OVER A PERIOD OF A COUPLE WEEKS ARE THEY STATING A HOLE IS IN THE CATHETER THEREFORE LEAKAGE IS OCCURRING? YES, THERE IS A HOLE AND LEAKAGE IS OCCURRING WHEN TRYING TO INJECT WHERE IS THE HOLE LOCATED? SOMEWHERE AROUND THE VALVE AND WHERE YOU CONNECT TO IV TUBING IT IT VISIBLE PRIOR TO USE? NO IS IT POSSIBLE THE NEEDLE PIERCED THE CATHETER WALL? NO, LEAKAGE OCCURS ON THE OUTSIDE PART OF THE CATHETER WHERE YOU CONNECT TO IV TUBING OR SYRINGE ( THE MED IS NEVER MAKING IT INTO THE BODY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297871 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251082 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown