BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 9008445 · Received September 12, 2019

    Report

    Report Number
    9610847-2019-00561
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 8, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8212735. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE INDWELLING NEEDLE GUIDE WIRE WAS OUT OF THE PRODUCT. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE INFUSION TO THE PATIENT, ACCORDING TO THE OPERATION PROCEDURE, THE INDWELLING NEEDLE GUIDE WIRE WAS FOUND TO HAVE COME OUT WHEN THE PRODUCT WAS FIRST EXAMINED. NOT APPLIED TO THE PATIENT AND DID NOT AFFECT THE PATIENT.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE OF THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM THE INDWELLING NEEDLE GUIDE WIRE WAS OUT OF THE PRODUCT. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE INFUSION TO THE PATIENT, ACCORDING TO THE OPERATION PROCEDURE, THE INDWELLING NEEDLE GUIDE WIRE WAS FOUND TO HAVE COME OUT WHEN THE PRODUCT WAS FIRST EXAMINED. NOT APPLIED TO THE PATIENT AND DID NOT AFFECT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799574 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212735 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other