BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 15670442 · Received October 25, 2022

    Report

    Report Number
    1710034-2022-00624
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 29, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER STATE: THIS INFORMATION WAS DETERMINED BASED ON THE AREA CODE PORTION OF THE PROVIDED PHONE #. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 21-OCT-2022. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES PROVIDED FOR EVALUATION. BD RECEIVED FOUR 22G X 1.00IN. INSYTE AUTOGUARD DISPENSER BOXES FROM LOT NUMBER 2171958. INSIDE EACH DISPENSER BOX WERE 50 SEALED 20G X 1.16IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 2171957. THE REPORTED ISSUE OF MIXED PRODUCT WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE PACKAGING PROCESS. MIXED LOTS MAY OCCUR DURING MANUFACTURING DUE TO IMPROPER LINE CLEARANCE BY OPERATORS OR AN IMPROPER LINE PURGE DUE TO EQUIPMENT SOFTWARE ERROR. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, THE LINE CLEARANCE INDICATED THAT THE LOT THAT WAS PREVIOUSLY PACKAGED PRIOR TO LOT NUMBER 2171958 WAS LOT NUMBER 2171957. THIS MAKES IT LIKELY THAT IMPROPER LINE CLEARANCE CONTRIBUTED TO THIS REPORT. OPERATORS ALSO PERFORM PERIODIC VISUAL INSPECTIONS PER THE QUALITY PLAN TO MITIGATE THE OCCURRENCE OF THIS DEFECT. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BOXES OF BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION ON BOX SAYS 22 GA, HOWEVER THERE ARE 20 GAUGE CATHETERS IN THE 4 BOXES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BOXES OF BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION ON BOX SAYS 22 GA, HOWEVER THERE ARE 20 GAUGE CATHETERS IN THE 4 BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572081 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2171958 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown