BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER 22 G X 1"

    MDR report key: 6863004 · Received September 13, 2017

    Report

    Report Number
    9610048-2017-00027
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    August 23, 2017
    Report Date
    October 18, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K950301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD ANGIOCATH¿ IV CATHETER 22 G X 1". PMA / 510(K)#: K950301.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CRYSTALS WERE FOUND IN BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 GA X 1.00 IN 0.9 X 25 MM DURING USE. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643765 BD ANGIOCATH¿ IV CATHETER 22 G X 1" INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7054849

    Patients

    Seq Age Sex Outcome Treatment
    1 Other