BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8332955 · Received February 12, 2019

    Report

    Report Number
    9610048-2019-00112
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    January 17, 2019
    Report Date
    March 20, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS ABLE TO VERIFY THE RETURNED DEVICE SAMPLE HAD DROPLETS OF SILICONE ON THE CATHETER PRESENT. IT SHOULD BE NOTED THAT THIS SILICONE DOES NOT CAUSE DAMAGE TO THE USER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. THE ROOT CAUSE OF THIS ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE CATHETER SILICONIZATION PROCESS. A CORRECTIVE ACTION PROJECT HAS BEEN INITIATED TO INVESTIGATE THE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE LOTS 7172785 REGARDING TESTS TO VERIFY "FOREIGN MATTER/ VISIBLE SILICONE" AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE CLAIMED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ANGIOCATH¿ IV CATHETER HAD DROPLETS ON THE SURFACE OF THE CANNULA.

    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 ANGIOCATH¿ IV CATHETER HAD DROPLETS ON THE SURFACE OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123075 BD ANGIOCATH¿ IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7172785 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other