BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8202983 · Received December 28, 2018

    Report

    Report Number
    9610048-2018-00218
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    November 9, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS ABLE TO VERIFY THE REPORTED ISSUE VIA THE PROVIDED PICTURE. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT #8141783 REGARDING ITEM #38183414. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY #8607681 LOT 8117908 MANUFACTURED FROM 03-MAY-18 TO 23-MAY-18 USED IN CLAIMED LOT 8141783. THE BATCH WAS ANALYZED FOR "NEEDLE RETRACTION" AND ¿PART ACTIVATION¿ TESTS, AND IT WAS NOT EVIDENCED RECORD OF FAILURE OF ACTIVATION OF THE PART DURING THE ANALYSIS OF THESE LOTS. NO RECORDS OF QUALITY NOTIFICATION OR REPORTS OF NON-CONFORMITY THAT COULD LEAD TO INCIDENT IN THE LOT INVOLVED IN THIS COMPLAINT WERE EVIDENCED. INVESTIGATION CONCLUSION: BD WAS ABLE TO VERIFY THE REPORTED ISSUE VIA THE PROVIDED PICTURE. ROOT CAUSE DESCRIPTION: NO OBJECTIVE EVIDENCE OF THIS INCIDENT WAS FOUND DURING THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS ANALYSIS FOR THE CLAIMED LOT, THEREFORE, WE WERE UNABLE TO DETERMINE AN EXACT ROOT CAUSE. 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 SAFETY LOCK DEVICE ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO RETRACT THE NEEDLE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 SAFETY LOCK DEVICE ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FAILED TO RETRACT THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044093 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8141783 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other