BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 7515070 · Received May 15, 2018

    Report

    Report Number
    9610847-2018-00138
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    April 6, 2018
    Report Date
    August 24, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SAMPLE WAS SUBMITTED FOR THE PURPOSE OF OUR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE OBSERVED BY OUR INVESTIGATIVE TEAM. BOTH SAMPLES HAD A FUNCTIONAL SAFETY DEVICE, HOWEVER ONE DEVICE DID HAVE A BENT NEEDLE UPON RECEIPT. THE DEVICE HISTORY REPORT FOR LOT NUMBER 7241750 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER 383318 FOR LOT 7241750 WAS MANUFACTURED ON 09/17/2017. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. ADDITIONALLY DURING THE MANUFACTURE OF THIS DEVICE QUALITY ASSURANCE TECHNICIANS CONDUCTED PULL FORCE TESTING TO VERIFY MACHINERY WAS OPERATING WITHIN SPECIFIED PARAMETERS. BASED ON THE SAMPLES THE ROOT CAUSE CANNOT BE FINALIZED BECAUSE THE INITIAL FAILURE MODE COULD NEITHER BE OBSERVED NOR REPLICATED. ADDITIONALLY THE FAILURE MODE OF NEEDLE BENT, ALTHOUGH OBSERVED, IS NOT RELATED WITH THE MANUFACTURING PROCESS. NO KNOWN COMPLICATIONS LEAD TO EITHER DEFECT. WE COULD NOT CONFIRM THE ISSUE AT OUR CUSTOMER FACILITY WITH THE PROVIDED INFORMATION. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. NO CORRECTIVE ACTION REQUIRED AT THE FAILURE. PROCESS FMEA RM4797 WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM MALFUNCTIONED AS "NEEDLE SAFETY FAILURE OCCURRED" THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM MALFUNCTIONED AS "NEEDLE SAFETY FAILURE OCCURRED" THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    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 AFTER USE A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM MALFUNCTIONED AS "NEEDLE SAFETY FAILURE OCCURRED" THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359221 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7241750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other