BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 18914111 · Received March 15, 2024

    Report

    Report Number
    1710034-2024-00189
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    March 13, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THIS MDR WAS CREATED DUE TO A SECOND LOT NUMBER PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING LEAKED PAST THE BLOOD CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD CONTROL VALUE OF THE IV DIDNT WORK UPON INSERTION 13 MAR 2024 CUSTOMER RESPONSE: THE MULTIPLE EVENTS OCCURRED ON DIFFERENT DAYS. YES, HCP UNEXPECTANTLY HAD EXPOSURE TO BLOOD. YES, ON ALL OCCASIONS, HCP WERE WEARING PPE. WHEN THE NEEDLE RETRACTED, THE IV STARTED DRIPPING BLOOD DOWN THE PATIENTS ARMS AND ONTO THE GLOVED HANDS OF THE HCP. THE EXPOSURE DID REQUIRE MEDICAL INTERVENTION BY HCP TO STOP THE FLOW OF THE BLOOD FROM THE PATIENT AND IN SOME CASES, THE IV NEEDED TO BE RESTARTED. HCP DID NOT REQUIRE MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    PLEASE PROVIDE LOT NUMBER. TWO EVENTS OCCURRED SAME DATE? IT IS STATED "HCP WAS EXPOSED TO BLOOD UNEXPECTEDLY" WAS THE HCP WEARING PPE? PLEASE DESCRIBE THE EXPOSURE REFERENCED. DID THIS EXPOSURE REQUIRE MEDICAL INTERVENTION? IF YES, DESCRIBE. #1. THERE ARE 3 LOT#'S IN QUESTION: 3055272, 3278270, 3153587. THERE ARE 2 DIFFERENT PRODUCT#'S IN QUESTION: 382512, 382612. #2. THE MULTIPLE EVENTS OCCURRED ON DIFFERENT DAYS. (I HAVE INCLUDED THE WRAPPERS FOR EACH.) ALL PRODUCT WERE SUPPOSED TO HAVE "BC" TECHNOLOGY.) #3. YES, HCP UNEXPECTEDLY HAD EXPOSURE TO BLOOD. #4. YES, ON ALL OCCASIONS, HCP WERE WEARING PPE. #5. WHEN THE NEEDLE RETRACTED, THE IV STARTED DRIPPING BLOOD DOWN THE PATIENT'S ARMS AND ONTO THE GLOVED HANDS OF THE HCP. #6. THE EXPOSURE DID REQUIRE MEDICAL INTERVENTION BY HCP TO STOP THE FLOW OF THE BLOOD FROM THE PATIENT AND IN SOME CASES, THE IV NEEDED TO BE RESTARTED. HCP DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485624 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3278270 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown