BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN

    MDR report key: 8241057 · Received January 11, 2019

    Report

    Report Number
    9610847-2018-00465
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 11, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833184
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 893508. OUR RECORDS SHOW THAT THIS IS THE SECOND 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. ALTHOUGH A PHOTOGRAPH WAS SUBMITTED FOR EVALUATION, IT WAS NOT CLEAR ENOUGH TO IDENTIFY THE FAILURE MODE ACCURATELY. WITHOUT THE AFFECTED SAMPLE WE WILL NOT BE ABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. THE REPORTED NEEDLE RETRACTION FAILURE WAS NOT CONFIRMED AFTER INSPECTING THE IMAGES PROVIDED. BASED ON INVESTIGATION RESULTS TO DATE, THE ROOT CAUSE COULD BE RELATED WITH LACK OF FOLLOWING WITH THE FOR PRODUCT USAGE RECOMMENDATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN HAD A NEEDLE THAT ONLY PARTIALLY RETRACTED IN THE SAFETY SHIELD.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 WITH PRN HAD A NEEDLE THAT ONLY PARTIALLY RETRACTED IN THE SAFETY SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31449 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8093508 00382903833184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other