BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19085261 · Received April 10, 2024

    Report

    Report Number
    1710034-2024-00315
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 20, 2024
    Report Date
    March 29, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS. THE FIRST IMAGE DISPLAYED THREE DISPENSER BOXES FROM WHAT APPEARED TO BE LOT #4010709. EACH DISPENSER BOX WAS LABELED WITH REFERENCE NUMBER 381434. THE PRODUCT DESCRIPTION ON THE LABEL (20 GA X 1.16 IN) WAS POSITIONED ON A BLUE BACKGROUND. 20 GA DEVICES COINCIDE WITH THE COLOR PINK AND THE BACKGROUND COLOR ON THE LABEL SHOULD HAVE BEEN PINK. THE CONTENTS OF THE DISPENSER BOX WERE NOT VISIBLE IN THE PHOTO. THE SECOND IMAGE DISPLAYED ONE DISPENSER BOX WITH THE SAME MATERIAL # WITH THE CORRECT PINK BACKGROUND. THE LOT # ON THE LABEL WAS 3277682. IT APPEARED THAT THIS IMAGE WAS USED AS A COMPARISON AND TO DEMONSTRATE THE CORRECT LABEL. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN INCORRECT MACHINE SET-UP IN THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHELF PACK IS INCORRECTLY LABELED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED SOME PRODUCT FROM MEDLINE IN PACKAGING THAT IS DIFFERENT FROM WHAT WE USUALLY SEE. PRODUCT INSIDE BLUE BOX IS THE 22 GA X 1 IN¿LABEL/REFERENCE ON BOX REFLECTS 20G PINK AUTOGUARD. MIS- LABELED LOT #4010709.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406885 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4010709 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown