BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 7735333 · Received July 31, 2018

    Report

    Report Number
    9610847-2018-00231
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 9, 2018
    Report Date
    August 27, 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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. THE DEVICE HISTORY REPORT FOR LOT NUMBER 6243927 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER (B)(4) FOR LOT 6243927WAS MANUFACTURED ON 08/31/2016. THIS IS THE FIRST INSTANCE OF THESE FAILURE MODES WITH THIS LOT NUMBER. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. A SAMPLE WAS PROVIDED FOR THE PURPOSE OF AIDING OUR QUALITY ENGINEER'S INVESTIGATION, DURING EVALUATION THE DEVICES WERE DETERMINED TO HAVE BROKEN TUBING, BENT NEEDLES, AND A SEPARATION BETWEEN THE STYLET AND NEEDLE COMPONENTS. BD ENGINEERS DETERMINE THE ROOT CAUSE FOR THIS EVENT TO BE RELATED TO PRODUCT USE, THIS CONCLUSION WAS REACHED AFTER VISUAL EVALUATION OF THE DEVICE IDENTIFIED A CUT IN THE TUBING THAT WAS CONSISTENT WITH SLIDE CLAMP DAMAGE. ONCE THE TUBING WAS LACERATED THE CLAMP MAY HAVE CONTRIBUTED TO THE DAMAGE IN THE STYLET. THE BENT NEEDLE OBSERVED BY THE BD INVESTIGATORS WAS MOST LIKELY THE RESULT OF TRANSPORTATION DAMAGE DURING THE RETURN OF THE SAMPLE. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. NO CORRECTIVE ACTION WAS PERFORMED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM THE NEEDLE BROKE IN HALF. IT WAS FURTHER CLARIFIED THAT WHEN PULLING THE SHIELD, THE NEEDLE BROKE WHILE STILL IN THE PATIENT'S ARM AND THE NEEDLE SEPARATED FROM THE GUIDE WIRE WHEN PULLING OUT THE SHIELD. WHILE REMOVING THE CATHETER, THE NEEDLE ALSO CAME OUT OF THE PATIENT'S ARM AS WELL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 THAT DURING THE USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE NEEDLE BROKE IN HALF. IT WAS FURTHER CLARIFIED THAT WHEN PULLING THE SHIELD, THE NEEDLE BROKE WHILE STILL IN THE PATIENT'S ARM AND THE NEEDLE SEPARATED FROM THE GUIDE WIRE WHEN PULLING OUT THE SHIELD. WHILE REMOVING THE CATHETER, THE NEEDLE ALSO CAME OUT OF THE PATIENT'S ARM AS WELL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578404 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6243927 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other