BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC PNK 20GA X 1.0IN

    MDR report key: 18237094 · Received November 30, 2023

    Report

    Report Number
    1710034-2023-01363
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 3, 2023
    Report Date
    January 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. PATIENT PROBLEM CODE: F24 - INSUFFICIENT INFORMATION. DEVICE PROBLEM CODE: A0510 - RETRACTION PROBLEM.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WAS CREATED IN ERROR. IT HAS BEEN IDENTIFIED THAT THE COMPLAINT RECORD ASSOCIATED WITH THIS MDR IS A DUPLICATE RECORD AND WILL BE CANCELLED.

    Description of Event or Problem · 0

    MATERIAL#: 382533. LOT#: 3178595, 3192270. IT WAS REPORTED BY THE CUSTOMER THAT SOME ARE LEAKING, SOME GET JAM AND DON'T RETRACK. VERBATIM: PLEASE SEE THE ATTACHED DOCUMENT FOR SOMES CUSTOMER RETURNS THAT CAME BACK AS DEFECTIVE I NEED TO RETURN FOR CREDIT. CAN YOU PLEASE ISSUE RA'S? PLEASE LET ME KNOW IF YOU NEED ANYTHING ELSE. THANK YOU, (B)(6).IM/NSP VENDOR REP (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044798 INSYTE AUTOG BC PNK 20GA X 1.0IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 3178595 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown