BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8166305 · Received December 14, 2018

    Report

    Report Number
    1710034-2018-00906
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 27, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE "PRINT WAS MISSING" ON FIVE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER PACKAGES. INVESTIGATION SUMMARY: RECEIVED FIVE UNUSED IAG 22GA UNITS IN SEALED PACKAGES FROM THE CATALOG NUMBER 381823, LOT NUMBER 8031891. TWO PHOTOS WERE SUBMITTED FOR EVALUATION. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE PRINT PERMANENCY WITH LOT #8031891 REGARDING ITEM #381823. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8031891. THE LOT NUMBER WAS BUILT ON AFA LINE 5 FROM 02FEB2018 THROUGH 07FEB2018. PACKAGED ON PACKAGING LINE 8 FROM 03FEB2018 THROUGH 12FEB2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. INVESTIGATION CONCLUSION: THE FIVE PACKAGES WERE MISSING FROM THE PAPER TOP WEB (LABEL); THE BD LOGO, REF NO., DESCRIPTION, LOT NUMBER AND THE EXPIRATION DATE. BASED ON THE EVALUATION OF THE SUBMITTED PHOTO; THE PHOTOS DISPLAYED THERE WAS MISSING PRINT FROM THE PACKAGE TOP WEB (LABEL). WHICH IS THE SAME FINDING AS THAT OF THE EVALUATION OF THE RETURNED UNITS. ROOT CAUSE DESCRIPTION: THERE IS A VISION SYSTEM THAT CHECKS FOR THE LOT NUMBER AND OTHER PRINT ON THE PACKAGE LABEL. THE PACKAGES THAT ARE MISSING PRINTED INFORMATION ARE REJECTED AND DUMPED INTO A SORTING BIN. WHEN THE BIN NEEDS TO BE EMPTIED, THE BIN IS REPLACED. ALL PACKAGES IN THE BIN ARE INSPECTED FOR PRODUCT ATTRIBUTE. THE ACCEPTABLE PACKAGES ARE PLACED INTO A LABELED DISPENSER; READY FOR PLACEMENT INTO THE SHIPPER. THE PRODUCT ASSOCIATED WITH THIS INCIDENT REPORT WAS NOT REMOVED DUE TO HUMAN ERROR. RATIONALE: A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE "PRINT WAS MISSING" ON FIVE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER PACKAGES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PRINT WAS MISSING" ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003050 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8031891 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other