BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 18887440 · Received March 12, 2024

    Report

    Report Number
    1710034-2024-00174
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 19, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826124
    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

    CORRECTION: LOT NUMBER WAS CONFIRMED AND ADDED INTO TAB D. ADDITIONAL INFORMATION ADDED TO TAB B.

    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-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    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.

    Description of Event or Problem · 0

    (B)(6) 2024 CUSTOMER RESPONSE ADDITIONAL INFORMATION RECEIVED: 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 PATIENTS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING BLOOD CONTROL DID NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD CONTROL VALUE OF THE IV DIDNT WORK UPON INSERTION QUERY RESPONSE: ¿ PLEASE PROVIDE ANY AVAILABLE PATIENT INFORMATION INCLUDING: AGE/ DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, RACE, OTHER RELEVANT HISTORY INCLUDING PREEXISTING MEDICAL CONDITIONS. THIS INFORMATION IS UNAVAILABLE. ¿ WHEN DID THE INCIDENT OCCUR? APPROXIMATELY 2-3 WEEKS AGO. ¿ HOW WAS TREATMENT COMPLETED FOR CUSTOMER? IV STICK (PRIMARY) WAS A ¿MISS.¿ SECOND IV WAS PLACED WITHOUT INCIDENT. ¿ DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PLEASE INCLUDE TREATMENT/INTERVENTION PROVIDED AND THE OUTCOME. SECOND IV WAS PLACED WITHOUT INCIDENT. NO HARM TO PATIENT. BC FUNCTION WORKED PROPERLY. ¿ PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. N/A ¿ CAN YOU PLEASE PROVIDE MORE DETAILS AND DESCRIBE HOW THE PRODUCT IS DAMAGED. A BLOOD CONTROL IV WAS PURCHASED. UPON USE OF THE IV IT WAS NOTED THAT THE BC EITHER DID NOT FUNCTION PROPERLY, OR WAS MISSING FROM THIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385429 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3055272 00382903826124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown