BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 14847160 · Received June 28, 2022

    Report

    Report Number
    9610048-2022-00066
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    May 31, 2022
    Report Date
    August 16, 2022
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811343
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD RECEIVED A 20 GAUGE ANGIOCATH DEVICE FROM LOT 7173824 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 DROPLETS OF SILICONE VISIBLE ON THE CATHETER. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ADHERED TO THE BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT FM ON CATHETER. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, WHEN THE HCP CHECKED THE APPEARANCE OF THE PRODUCT, SOMETHING FLOSSY WAS FOUND TO BE ADHERING TO THE CATHETER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ADHERED TO THE BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT FM ON CATHETER. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, WHEN THE HCP CHECKED THE APPEARANCE OF THE PRODUCT, SOMETHING FLOSSY WAS FOUND TO BE ADHERING TO THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813241 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381134 7173824 30382903811343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown