BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 7452124 · Received April 23, 2018

    Report

    Report Number
    9610847-2018-00089
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    April 3, 2018
    Report Date
    May 15, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833221
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE ACTUAL SAMPLE WAS RETURNED TO BD FOR EVALUATION. LEAK TESTING OF THE RETURNED UNIT CONFIRMED LEAKAGE FROM A PUNCTURE NEAR THE CATHETER/INSERTER JUNCTION. WE WERE UNABLE TO CONFIRM THE DAMAGE TO THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6243979. REPORTED DEFECT WAS CONFIRMED IN SAMPLE RECEIVED; HOWEVER, THE HOLE FOUND IN THE CATHETER CAUSED BY THE CANNULA IS NOT ASSOCIATE TO MANUFACTURING PROCESS. THIS DEFECT COULD BE RELATED WITH AN INCORRECT USE OF THE PRODUCT, THE CHARACTERISTIC THAT SHOWED THE CATHETER IN FORM ¿ V ¿, IT COULD BE RELATED WITH THE ACTIVATION PERFORMED FROM THE ADAPTER CLEAR PRN, IT MAKES THE MEMORY OF MATERIAL (TUBING) WILL CAUSE A ¿SLING SHOT¿ SENDING THE NEEDLE TO HIS ORIGINAL POSITION RESULTING IN A CATHETER PIERCE. PRODUCT IS FUNCTIONAL TESTED AND NO INCIDENTS WITH LEAKAGE FAILURE HAS BEEN REPORTED. INVESTIGATION CONCLUSION: BASED ON INVESTIGATION RESULTS TO DATE ROOT CAUSE CANNOT BE DETERMINED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT BLOOD LEAKED BETWEEN THE CONNECTION OF THE CATHETER TUBING AND ADAPTER OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. FOUND DURING USE. NO REPORTS OF EXPOSURE TO BLOOD, SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292592 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6243979 00382903833221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other