BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8209573 · Received January 2, 2019

    Report

    Report Number
    9610048-2018-00221
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    November 3, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    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: NO SAMPLES OR PHOTOS ARE AVAILABLE FOR ANALYSIS. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT #8061973 REGARDING ITEM #38182314. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY #8607679 LOT 8057538 MANUFACTURED FROM 02-MAR-18 TO 29-MAR-18 USED IN CLAIMED LOT 8061973. THE BATCH WAS ANALYZED FOR "NEEDLE RETRACTION" AND ¿PART ACTIVATION¿ TESTS, NO RECORD OF FAILURE OF ACTIVATION OF THE PART DURING THE ANALYSIS OF THESE LOTS WAS FOUND. A QUALITY NOTIFICATION FOR THE "GEL WEIGHT OUT OF SPECIFIED" DEFECT WAS FOUND. HOWEVER, BD CANNOT AFFIRM THAT THIS NONCONFORMITY IS DIRECTLY RELATED TO THIS DEFECT. INVESTIGATION CONCLUSION: BD WAS ABLE TO VERIFY THIS REPORTED ISSUE WITHOUT A RETURNED SAMPLE DUE TO THERE BEING ANOTHER REPORTED ISSUE FROM THE SAME BATCH. NO OBJECTIVE EVIDENCE OF THIS INCIDENT WAS FOUND DURING THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS ANALYSIS FOR THE CLAIMED LOT. ROOT CAUSE DESCRIPTION: BASED ON THE RESULTS OF THE INVESTIGATION TO DATE A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THE DEFECT DESCRIBED IN 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 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DID NOT RETRACT.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DID NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3680 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8061973 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other