BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 8575997 · Received May 2, 2019

    Report

    Report Number
    9610847-2019-00350
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 28, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833239
    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

    THE CORRECTIONS ARE AS FOLLOWS: D. 1 MEDICAL DEVICE TYPE: FOZ. G.5. PMA / 510(K)#: K013800.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8025673. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A BROKEN NEEDLE 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. DURING OUR REVIEW OF THE DEVICE SUBMITTED, IT WAS DETERMINED THAT THE DAMAGED SECTION OF THE DEVICE WAS A THINNER SECTION OF THE CANNULA, THE THINNER DESIGN IS INTENDED TO DETECT FLASHBACK DURING USE. ADDITIONALLY, EVERY SAF-T-INIMA IS VISUALLY INSPECTED FOR THIS TYPE OF DEFECT PRIOR TO RELEASE FROM THE MANUFACTURING FACILITY AND THE THINNER DESIGN MEANS THAT POST-PRODUCTION DAMAGE CAN OCCUR DURING SHIPPING, STORAGE, OR UNPACKAGING. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS FOUND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NEEDLE WAS FOUND BROKEN AT THE NOTCH AREA WHEN UNPACKED. THE CATHETER WAS ACTIVATED WHEN THE NURSE SHOWED THE ISSUE TO SALES REP."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS FOUND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NEEDLE WAS FOUND BROKEN AT THE NOTCH AREA WHEN UNPACKED. THE CATHETER WAS ACTIVATED WHEN THE NURSE SHOWED THE ISSUE TO SALES REP."

    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 A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS FOUND BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NEEDLE WAS FOUND BROKEN AT THE NOTCH AREA WHEN UNPACKED. THE CATHETER WAS ACTIVATED WHEN THE NURSE SHOWED THE ISSUE TO SALES REP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369611 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8025673 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1 Other