BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 7531104 · Received May 21, 2018

    Report

    Report Number
    9610847-2018-00147
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 18, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833238
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS OCCURRENCE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7083683. INVESTIGATION CONCLUSION: WITHOUT SAMPLE OR PHOTO DEFECTIVE WE CANNOT CONFIRM THE REPORTED DEFECT TO MANUFACTURING PROCESS. CUSTOMER REPORTED CATHETER HAD LEAKAGE NEAR THE WINGS; HOWEVER, NO SAMPLE WAS AVAILABLE FOR EVALUATION WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION; SINCE, WE CANNOT TO DETERMINATE IF THE LEAKAGE WAS CAUSED BY THE CANNULA OR BY AN INCORRECT ASSEMBLY. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. PRODUCT IS FUNCTIONAL TESTED, NO INCIDENTS WITH NEEDLE BENT HAVE BEEN REPORTED. NO CORRECTIVE ACTION REQUIRED AT THE FAILURE. PROCESS FMEA (B)(4) WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. ALWAYS REFER TO IFU FOR PRODUCT USAGE RECOMMENDATIONS. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. ROOT CAUSE DESCRIPTION: WITHOUT SAMPLE OR PHOTO DEFECTIVE WE CANNOT TO DETERMINATE THE ROOT CAUSE. RATIONALE: NO CAPA WAS OPENED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD A LEAK NEAR THE WINGS. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372806 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7083683 00382903833238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other