BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH IV CATHETER

    MDR report key: 10052627 · Received May 13, 2020

    Report

    Report Number
    9610048-2020-00072
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    April 7, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903811236
    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 SUMMARY BD RECEIVED FIFTY-EIGHT UNUSED 22 GAUGE ANGIOCATH UNIS FROM LOT 8180688 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 UNITS AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE TO THE ADAPTER THAT COULD LEAD TO A LEAK. NEXT, A LEAKAGE TEST WAS PERFORMED ON THE UNITS AND NO LEAKAGE WAS OBSERVED. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE OBSERVED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH¿ IV CATHETER LEAKED ON 5 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, BLOOD LEAKED FROM THE CONNECTION WHEN CONNECTING WITH INFUSION SET. THE ISSUE OCCURRED SOME TIMES IN SOME LOTS. EVERY TIME WHEN THE ISSUE OCCURRED, REPLACED BY NEW ANGIOCATH.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ANGIOCATH IV CATHETER LEAKED ON 5 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, BLOOD LEAKED FROM THE CONNECTION WHEN CONNECTING WITH INFUSION SET. THE ISSUE OCCURRED SOME TIMES IN SOME LOTS. EVERY TIME WHEN THE ISSUE OCCURRED, REPLACED BY NEW ANGIOCATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517957 BD ANGIOCATH IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8180688 00382903811236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other