BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ IV CATHETER

    MDR report key: 9315804 · Received November 13, 2019

    Report

    Report Number
    9610048-2019-00329
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 17, 2019
    Report Date
    December 6, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF DEFECT FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 7221977, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. ACCORDING TO THE VISUAL ANALYSIS OF THE SAMPLE PHOTO THE DAMAGE TO THE CATHETER TIP CANNOT BE OBSERVED AS PER THE CUSTOMER'S REPORT AND THE DAMAGE TO THE BASE ON THE ADAPTER CAUSING THE REPORTED LEAKAGE CANNOT BE OBSERVED. CONCLUSION(S): FOR CATHETER TIP INTEGRITY DEFECT - NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE CLAIM FOR THE DEFECT CLAIMED. IN ADDITION TO THE FACT THAT NO RECORDS WERE FOUND THAT COULD CAUSE THIS CLAIM DURING THE ANALYSIS OF BATCH HISTORY AND NON-CONFORMITIES, WITHOUT SAMPLES OR PHOTOS FOR ANALYSIS, IT IS NOT POSSIBLE TO CONFIRM THE DEFECTS REPORTED IN THIS COMPLAINT. FOR ADAPTER / CONNECTOR / DEFECTIVE / DAMAGED DEFECT CONFIRMED: BD CAN CONFIRM THE CUSTOMER COMPLAINT FOR THE CLAIMED DEFECT. BASED ON RESEARCH RESULTS TO DATE ACCORDING TO CORRECTIVE MAINTENANCE HISTORY TIP . MISALIGNMENT OF THE INDEX.. CAPA 1302123 WAS OPENED TO INVESTIGATE AND IDENTIFY CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER LEAKED. THIS OCCURRED ON 50 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY PRESENT LEAK IN THE BASE OF THE CONNECTION CONE OF THE CATHETER AT THE TIME OF ENTERING IT. THE CATHETERS OPEN AT THE TIME OF ENTERING IT. BATCH CHANGE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER LEAKED. THIS OCCURRED ON 50 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY PRESENT LEAK IN THE BASE OF THE CONNECTION CONE OF THE CATHETER AT THE TIME OF ENTERING IT. THE CATHETERS OPEN AT THE TIME OF ENTERING IT. BATCH CHANGE IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108398 BD INSYTE¿ IV CATHETER N/A FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7221977

    Patients

    Seq Age Sex Outcome Treatment
    1 Other