BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19195541 · Received April 26, 2024

    Report

    Report Number
    2243072-2024-00575
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. IN THIS MDR, BD (B)(4) NJ HAS BEEN LISTED IN SECTIONS AS THE MANUFACTURING SITE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    A LOT NUMBER WAS RECEIVED AND HAS BEEN INCLUDED. CORRECTION CANCEL MDR: AN EMAIL STATING THAT THE INVIMA STICKER IS NOT PROVIDED BY BD HAS BEEN RECEIVED. IT IS A SANITARY REGISTRATION# STICKER IS FROM INVIMA, AND THIS IS NOT PLACED BY THE BD PLANT, THIS IS A LOCAL PROCESS. AS NO PRODUCT QUALITY ISSUE IS REPORTED, THIS DOES NOT QUALIFY AS A BD PRODUCT COMPLAINT. THE COMPLAINT WILL BE CLOSED / CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD PACKAGE STICKERS ARE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: DURING THE INSPECTION, IMPORTED MEDICAL DEVICES WERE FOUND THAT DID NOT HAVE PACKAGING STICKERS ON THEIR PACKAGING. SERVICE FOR THE PERTINENT MANAGEMENT WITH THE SUPPLIER.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879710 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON 3342336 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown