BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH IV CATHETER

    MDR report key: 11342886 · Received February 18, 2021

    Report

    Report Number
    9610048-2021-00022
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 24 GAUGE ANGIOCATH UNIT FROM LOT 9031925 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED A PIECE OF FOREIGN MATTER (FM) ON THE CATHETER. A PIECE OF THE FM WAS COLLECTED AND SENT FOR FTIR ANALYSIS. THE ANALYSIS DETERMINED THAT IT WAS GREASE MIXED WITH SILICONE THAT WAS FOUND ON THE CATHETER. THESE SUBSTANCES WERE USED DURING THE CATHETER POINTING PROCESS. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THE FM CAME FROM THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE BD ANGIOCATH¿ IV CATHETER TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "BEFORE USE, THE HCP FOUND AN FM ON THE CATHETER TIP."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE BD ANGIOCATH¿ IV CATHETER TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "BEFORE USE, THE HCP FOUND AN FM ON THE CATHETER TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243863 BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381112 9031925 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1