BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOG BC PNK 20GA X 1.16IN

    MDR report key: 17995691 · Received October 24, 2023

    Report

    Report Number
    1710034-2023-01219
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    October 5, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825340
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC PNK 20GA X 1.16IN WAS DIFFICULT TO THREAD IN A PATIENT PRESENTING IN ANAPHYLACTIC SHOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ANOTHER INCIDENT WITH YET ANOTHER LOT # TODAY- COULD HAVE CREATED A SENTINEL EVENT. A PATIENT IN ANAPHYLACTIC SHOCK BROUGHT IN BY PRIVATE CAR WAS RUSHED INTO OUR RESUSCITATION BAY, UNRESPONSIVE WITH A VERY THREADY PULSE. AS MY STAFF ATTEMPTED TO GAIN IV ACCESS, 2 SEPARATE RN'S HAD TROUBLE PUNCTURING THE SKIN AND ADVANCING THE CATHETER- 1 WAS SUCCESSFUL, 1 WAS NOT. I CANNOT OVERSTATE HOW CRITICAL IT WAS TO ESTABLISH AN IV ON THIS PATIENT FOR LIFESAVING INTERVENTIONS. 2 ADDITIONAL ATTEMPTS WITH THE 20 IV WERE UNSUCCESSFUL. THIS IS A NEW LOT # 3192266. ADDITIONAL INFO FROM CUSTOMER: (12-OCT-2023): WHAT IS THE QUANTITY OF PRODUCTS FOUND DEFECTIVE? SHARPNESS OF THE NEEDLE. IS THERE ANY ADVERSE EVENT OR SERIOUS INJURY OCCURRED? DELAY IN TREATMENT. ARE YOU ABLE TO SEND SAMPLES TO BD FOR INVESTIGATION? IF NO, CAN A PHOTO BE PROVIDED? NONE. WAS THERE DIFFICULTY PUNCTURING THE SKIN AND ADVANCING ONCE IN THE VEIN? YES TO BOTH. DID THE NEEDLE APPEAR DULL OR AS IF THE NEEDLE WAS ADHERED TO THE CATHETER? NEEDLE APPEARED TO BE DULL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157537 BD INSYTE AUTOG BC PNK 20GA X 1.16IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192266 30382903825340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening