BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 7076106 · Received December 1, 2017

    Report

    Report Number
    9610847-2017-00167
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 14, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K923702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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 6243989. CONCLUSION: BOTH REPORTED DEFECTS WERE NOT CONFIRMED EITHER ASSOCIATE TO THE MFG. PROCESS, BECAUSE WITHOUT DEFECTIVE SAMPLE OR PHOTO FOR US IS VERY DIFFICULT TO DETERMINATE THE ROOT OF CAUSE. DURING ASSEMBLY OF THIS PRODUCT WE HAD NOT ISSUES OF LEAKAGE AND SEPARATION. CURRENT WE HAVE THE ADEQUATE CONTROLS TO DETECT THESE TYPES OF DEFECTS. NO ROOT CAUSE OF THE ISSUE SINCE NO SAMPLE OR PHOTO WAS RETURNED FOR EVALUATION. NO CAPA WAS OPENED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE TUBING SEPARATED FROM THE HUB OF CATHETER CAUSING LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854039 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVENOUS CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6243989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other