BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 7196777 · Received January 16, 2018

    Report

    Report Number
    9610847-2017-00232
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 26, 2017
    Report Date
    February 19, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K923702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER'S PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: ONE REPRESENTATIVE UNIT WAS RECEIVED FOR ANALYSIS. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND NO PHYSICAL OR MECHANICAL DAMAGE OR FOREIGN MATTER WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 6243989. WE WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT. REPORTED DEFECT WAS NOT CONFIRMED IN REPRESENTATIVE SAMPLE; SINCE, DURING THE INSPECTION OF THIS SAMPLE WE DO NOT FIND FOREIGN MATTER IN THE CATHETER TIP OR NEEDLE TIP. CERTIFICATE OF STERILITY FOR THIS REPORTED LOT NUMBER 6243989 WAS REVIEWED AND ALL THE UNITS (B)(4) MEET WITH ACCEPTANCE CRITERIA. WE CANNOT CONFIRM OR ASSOCIATE THIS REPORTED DEFECT TO MANUFACTURING PROCESS. NO CAPA WAS OPENED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER PLACEMENT OF THE BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM, ON SEVERAL OCCASIONS, ¿ALLERGIC REACTION, ABSCESS, INFECTION¿ WAS NOTED. THERE WAS NO REPORT OF ANY MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36788 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6243989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other