BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7201779 · Received January 17, 2018

    Report

    Report Number
    9610847-2017-00236
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 27, 2017
    Report Date
    February 21, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K923702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6243978. ONE USED UNIT AND SEVEN UNUSED UNITS WERE RECEIVED FOR ANALYSIS. OUR QUALITY ENGINEER VISUALLY INSPECTED THE USED UNIT AND CONFIRMED THAT THE NEEDLE HAD SEPARATED FROM THE STYLET. THIS PRODUCT IS ASSEMBLED MANUALLY AND THIS DEFECT IS RELATED TO AN INCORRECT PLACEMENT OF THE STYLET INTO THE NEEDLE. 7 REPRESENTATIVE SAMPLES WERE FUNCTIONALLY TESTED, ALL THESE SAMPLES MET WITH ACCEPTANCE CRITERIA AFTER PERFORM PULL TEST BETWEEN NEEDLE/ STYLET. NEEDLE/ STYLET (PULL TEST): AVERAGE: 14.95 POUNDS, MINIMUM: 13.82 POUNDS, MAXIMUM: 15.67 POUNDS, SPECIFICATION: 9.0 POUNDS (MINIMUM). INVESTIGATION CONCLUSION: BASED ON EVALUATION (USED UNIT), WE CAN CONFIRM AND ASSOCIATE THE DEFECT TO MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM NEEDLE CAME LOOSE FROM THE YELLOW BUTTERFLY AND STARTED FLOWING UP INTO THE INTIMA TUBE. THE NURSE WAS ABLE TO CATCH THE NEEDLE BEFORE IT WENT TO THE PATIENT. OBSERVED DURING USE. NO SERIOUS INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42652 BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6243978 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other