BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9695787 · Received February 11, 2020

    Report

    Report Number
    9610048-2020-00019
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    November 6, 2019
    Report Date
    February 17, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: B.3. DATE OF EVENT: (B)(6) 2019. H.6. INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR FINAL PRODUCT CATALOG #38186714 LOT 8180829 MANUFACTURED FROM 03-JUL-2018 IN MULTIVAC R530-1 PACKAGE MACHINE. THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE¿ OR ANYTHING THAT COULD LEAD TO BE RELATED TO THIS COMPLAINT. THE CORRECTIVE MAINTENANCE HISTORY IN THE MANUFACTURING PERIOD OF THE PACKAGING OF THIS COMPLAINT WAS EVALUATED AND IT WAS NOT VERIFIED RECORDS THAT COULD LEAD TO "PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE¿ DEFECT FOR THE CLAIMED LOT. THIS COMPLAINT DOES NOT CONTAIN SAMPLES OR PHOTOS FOR ANALYSIS. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE WITH LOT #8180829 REGARDING ITEM #38186714. ROOT CAUSE DESCRIPTION: BASED ON THE RESULTS OF THE INVESTIGATION SO FOR A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THE DEFECT OF THIS COMPLAINT. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. THE INFORMATION WILL BE CAPTURED IN THE TREND REPORTS AND MONITORED MONTHLY. COLLECTED DATA ARE REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING OPENS EASILY AND STERILITY IS IN QUESTION WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THIS OCCURRED ON 4 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: VIOLATED PACKAGING DURING STORAGE, OPENS VERY EASILY, WITH LOSS OF STERILITY AND NEED FOR DISPOSAL.

    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 PACKAGING OPENS EASILY AND STERILITY IS IN QUESTION WITH A BD INSYTE AUTOGUARD SHIELDED IV CATHETER. THIS OCCURRED ON 4 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: VIOLATED PACKAGING DURING STORAGE, OPENS VERY EASILY, WITH LOSS OF STERILITY AND NEED FOR DISPOSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160233 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8180829

    Patients

    Seq Age Sex Outcome Treatment
    1 Other