BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 8667896 · Received June 4, 2019

    Report

    Report Number
    9610847-2019-00401
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 22, 2019
    Report Date
    August 12, 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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8212731. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF MISLABELING 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. BASED ON SAMPLES EVALUATION, THE DEFECT LABEL CONTENT INCORRECT COULD BE IDENTIFIED AND CONFIRMED. OUR ENGINEERS WERE ABLE TO DETERMINE THAT THE EVENT OCCURRED POST-MANUFACTURE, AT OUR DISTRIBUTION CENTER IN CHINA. THE ROOT CAUSE WAS DETERMINED TO BE EMPLOYEE NEGLIGENCE, TO ADDRESS THIS EVENT OUR DISTRIBUTION HAS RETRAINED THE RELEVANT EMPLOYEES IN ORDER TO RAISE AWARENESS OF THIS EVENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABEL INFORMATION FOR QUANTITY DID NOT MATCH ACTUAL QUANTITY WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. QUANTITY AFFECTED BY THIS OCCURRENCE IS150. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT'S BEEN NOTICED THAT THE PRODUCT QUANTITY ON THE CHINESE LABEL (MARKED 50PCS) WAS NOT MATCHED WITH THE REAL PRODUCT QUANTITY (25PCS). IT'S THE LABEL CONTENT ERROR.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 LABEL INFORMATION FOR QUANTITY DID NOT MATCH ACTUAL QUANTITY WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. QUANTITY AFFECTED BY THIS OCCURRENCE IS150. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT'S BEEN NOTICED THAT THE PRODUCT QUANTITY ON THE CHINESE LABEL (MARKED 50PCS) WAS NOT MATCHED WITH THE REAL PRODUCT QUANTITY (25PCS). IT'S THE LABEL CONTENT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461519 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212731 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other