BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM

    MDR report key: 8204629 · Received December 28, 2018

    Report

    Report Number
    9610847-2018-00444
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 1, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833123
    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 REVIEW WAS CONDUCTED FOR LOT NUMBER 7327621. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY OUR QUALITY ENGINEERS HAVE REVIEWED THE SAMPLES SUBMITTED, AND DURING LEAKAGE TESTING THEY DETERMINED THAT THE ONLY LEAKS PRESENT IN THE DEVICE WERE FOUND AT THE PUNCTURE POINTS IN THE CATHETER TUBING. IN RESPONSE TO THE DAMAGED CATHETER OUR ENGINEERS CONDUCTED A REVIEW OF THE MANUFACTURING PROCESS BUT WERE UNABLE TO IDENTIFY ANY OPPORTUNITIES TO GENERATE THIS FAILURE MODE IN OUR MANUFACTURING PROCESS. THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. THE REPORTED LEAKAGE AND NEEDLE THROUGH CATHETER WERE CONFIRMED IN BOTH SAMPLES AFTER TO BE INSPECTING. BASED ON INVESTIGATION RESULTS TO DATE, THE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, BY THE CONDITIONS OF THE DEFECT A POSSIBLE CAUSE COULD BE THE INCORRECT USE FROM PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM LEAKED AND THE NEEDLE PIERCED THROUGH THE CATHETER.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7327621; MEDICAL DEVICE EXPIRATION DATE: 2021-11-30; DEVICE MANUFACTURE DATE: 2017-12-01. MEDICAL DEVICE LOT #: 6060981; MEDICAL DEVICE EXPIRATION DATE: 2020-03-31; DEVICE MANUFACTURE DATE: 2016-03-12. 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 BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM LEAKED AND THE NEEDLE PIERCED THROUGH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044022 BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10. 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other