BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8337602 · Received February 13, 2019

    Report

    Report Number
    9610048-2019-00114
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    December 22, 2018
    Report Date
    February 13, 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 · 1

    (B)(6). INVESTIGATION SUMMARY: BD WAS UNABLE TO VERIFY THE REPORTED CLAIM OF THE CATHETER STUCK IN THE CATHETER'S PROTECTIVE CAP, AS THE SAMPLE WAS WITHOUT THE CATHETER. HOWEVER, IT WAS VERIFIED THAT THERE WAS FAILURE OF RETRACTION IN THE NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY #8607681 LOT 8178728 MANUFACTURED FROM 11-JUN-18 TO 31-JUN-18 USED IN CLAIMED LOT 8191865. THE BATCH WAS ANALYZED FOR "DAMAGED COMPONENT¿ TESTS, AND IT WAS NOT EVIDENCED OF THE PART DURING THE ANALYSIS AND DAMAGED COMPONENT OF THESE LOTS. THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "DAMAGED COMPONENT" OR ANYTHING THAT COULD LEAD TO THIS COMPLAINT. INVESTIGATION CONCLUSION: NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE CLAIM. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE IS UNDETERMINED, IT SHOULD BE NOTED THE SAMPLE IS CONTAMINATED AND THE COAGULATED BLOOD IN THE CHAMBER CAN AFFECT THE DEVICE'S ABILITY TO RETRACT. 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 IS REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SILICONE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS STUCK IN THE PROTECTIVE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131202 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8191865 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other