BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 9955861 · Received April 13, 2020

    Report

    Report Number
    9610847-2020-00128
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    March 20, 2020
    Report Date
    May 19, 2020
    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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9210990 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, THE CATHETER WAS OBSERVED BROKEN. THE QUALITY ENGINEER TEAM ATTEMPTED TO REPRODUCE THE OBSERVED DEFECT THROUGH FUNCTIONALLY TESTING THE SAME CATHETER MATERIAL WITHIN THE MANUFACTURING FACILITY; HOWEVER, THE DEFECT COULD NOT BE REPLICATED. IT IS SUSPECTED THAT SOMETHING EXTRAORDINARY OCCURRED DURING THE ACTIVATION OF THE DEVICE, WHICH RESULTED IN THE DAMAGED CATHETER. AT THIS TIME, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM BROKE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PLACING THE DEVICE AND REMOVING THE NEEDLE IT WAS NOTICED THAT THERE WAS BLOOD AND LIQUID LEAKAGE. THE DEVICE HAS BEEN REMOVED AND THEY NOTICED A MISSING PART WITH THE CATHETER BROKEN. THE PATIENT (CHILDREN) HAS BEEN TESTED WITH X-RAY BUT THE RESULT WAS NEGATIVE.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/ OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM BROKE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PLACING THE DEVICE AND REMOVING THE NEEDLE IT WAS NOTICED THAT THERE WAS BLOOD AND LIQUID LEAKAGE. THE DEVICE HAS BEEN REMOVED AND THEY NOTICED A MISSING PART WITH THE CATHETER BROKEN. THE PATIENT (CHILDREN) HAS BEEN TESTED WITH X-RAY BUT THE RESULT WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419199 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM N/A FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9210990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention