BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 7203067 · Received January 18, 2018

    Report

    Report Number
    9610847-2017-00234
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    December 27, 2017
    Report Date
    March 9, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS OCCURRENCE. ACCORDING DESCRIPTION THE CUSTOMER NEEDLE IS BREAKING OFF DURING USE. THIS PRODUCT HAS 2 COMPONENTS. A STYLET WIRE AND A NEEDLE. THIS LAST HAS AN AREA CALLED ¿NOTCH AREA¿. ITS FUNCTION IS TO DETECT FLASH BACK AND IF, DURING USE THIS PART IS STRESSED, COULD CAUSE THE REPORTED DEFECT. DHR FOR LOT NUMBER 7083680 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL 383313 WITH LOT NUMBER 7083680 WAS MANUFACTURED ON MARCH 31, 2017. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. DURING DHR REVIEW THE QA TECH TAKES 635 SAMPLES TO VISUAL INSPECTION BY (STYLET AND NEEDLE BENT), NO DEFECTS WERE FOUND IN FINAL ASSEMBLY. DURING DHR REVIEW THE QA TECH TAKES 5,000 SAMPLES TO VISUAL INSPECTION BY (STYLET BENT, NEEDLE BENT AND MISSING COMPONENT ETC). ADDITIONALLY ALL FUNCTIONAL TEST MEETS SPECIFICATION CRITERIA REQUESTED DURING MANUFACTURING. WITHOUT DEFECTIVE SAMPLE OR PHOTO FOR US IS VERY DIFFICULT TO DETERMINATE THE ROOT OF CAUSE FOR THIS REASON WE WERE NOT ABLE TO ASSOCIATE THE REPORTED DEFECT TO THE MFG. PROCESS. 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 NEEDLE ON A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM CAME LOOSE FROM THE BUTTERFLY AND STARTED FLOWING UP INTO THE TUBE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46877 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7083680 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other