BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER

    MDR report key: 7602215 · Received June 14, 2018

    Report

    Report Number
    9610847-2018-00185
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 25, 2018
    Report Date
    August 23, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833351
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REPORT FOR LOT NUMBER 6180743 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER 383335 FOR LOT 6180743 WAS MANUFACTURED ON 07/06/2016. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. ADDITIONALLY BOTH A PHOTO AND SAMPLE WERE PROVIDED TO AID OUR QUALITY ENGINEER IN THEIR INVESTIGATION. THESE SAMPLES DISPLAYED THE REPORTED FAILURE MODE, INVESTIGATORS NOTED THAT THE DEVICE WAS SUBJECTED TO LEAKAGE TESTING WHICH PRODUCED A LEAK IN THE EXTENSION TUBING NEAR THE ADAPTER. FURTHER INVESTIGATION BY WAY OF MICROSCOPE REVEALED A SMALL PUNCTURE MARK IN THE EXTENSION TUBING. BASED ON THE DIMENSIONS OF THE HOLE THE MOST LIKELY CAUSE IS THAT THE TUBING WAS PUNCTURED BY THE CANNULA OF THE DEVICE, HOWEVER, THIS CONCLUSION CANNOT BE VERIFIED. THIS TYPE OF DAMAGE IS NOT RELATED TO THE MANUFACTURING PROCESS, THE CANNULA IS COVERED WITH A NEEDLE COVER DURING THE FABRICATION OF THE DEVICE, TO ELIMINATE THE OCCURRENCE OF THIS TYPE OF DEFECT. NO CAPA WAS OPENED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    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: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE FOUND BLOOD LEAKING AT THE E-TUBING SITE, NEAR THE PRN ROOT USING THE BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE FOUND BLOOD LEAKING AT THE E-TUBING SITE, NEAR THE PRN ROOT USING THE BD SAF-T-INTIMA INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    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 THE NURSE FOUND BLOOD LEAKING AT THE E-TUBING SITE, NEAR THE PRN ROOT USING THE BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442359 BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, REMOVABLE PRN ADAPTER INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6180743 00382903833351

    Patients

    Seq Age Sex Outcome Treatment
    1 Other