BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC WING PNK 20GA X 1.0IN

    MDR report key: 20903385 · Received December 11, 2024

    Report

    Report Number
    1710034-2024-01471
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 25, 2024
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    Description of Event or Problem · 0

    MATERIAL #:382633, BATCH#:4222721. IT WAS REPORTED BY CUSTOMER THAT THE WHEN INSERTING AN IV CATHETER, WE DO NOT GET FLASH IN THE CATHETER OR IN THE HUB, IT IS USUALLY IN THE PLASTIC CATHETER THAT HOUSES THE RETRACTED NEEDLE. ALSO, WHEN INSERTING THE CATHETER, YOU HAVE TO ADVANCE THE NEEDLE MORE THAN USUAL AS IT CAN BE DIFFICULT TO ADVANCE JUST THE PLASTIC CATHETER. WHEN YOU PUSH THE BUTTON TO RETRACT THE NEEDLE, THE NEEDLE DOES NOT RETRACT. ITS LIKE THE BUTTON STICKS, YOU HAVE TO PUSH THE BUTTON SEVERAL TIMES TO HAVE IT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597747 INSYTE AUTOG BC WING PNK 20GA X 1.0IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4222721 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown