BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 5661343 · Received May 17, 2016

    Report

    Report Number
    9610048-2016-00002
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    May 2, 2016
    Report Date
    June 14, 2016
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    TWO REPRESENTATIVE SAMPLES IN SEALED PACKAGES WERE RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED THAT THERE WAS NO FOREIGN MATTER ON ANY OF THE UNITS. THE BEVEL AREA HAD THE PROPER BEVEL CUT AND THE SECONDARY BEVEL WAS PRESENT. THE LIE DISTANCE WAS WITHIN THE ACCEPTABLE RANGE OF .001 - 0.023 INCHES. THE CANNULA TIP QUALITY ON BOTH UNITS RATED B - ACCEPTABLE. NO BENDS HOLES, KINKS SPLITS OR WRINKLES WERE FOUND IN THE CATHETER TUBING. THE CATHETER TIP GRADING FOR BOTH UNITS GRADED A 5 (SLIGHTLY ROUGH OR UNEVEN EDGE TO CLEAN SHARP EDGE) - ACCEPTABLE. A PACKAGE LEAK TEST WAS PERFORMED AND REVEALED NO LEAKS OR OPENED SEALS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5203334. THE STERILIZATION PROCESS WAS ALSO REVIEWED AND NO ABNORMALITIES WERE FOUND. A QUALITY NOTIFICATION REVIE REVEALED ONE QN ((B)(4)) THAT COULD BE ASSOCIATED WITH THIS INCIDENT. THE QN INVOLVED JAGGED TIP, O-RINGS AND FLASHED TIPS. THE SUSPECT PRODUCT WAS SCRAPPED AND IS NOT BE AN ISSUE FOR THIS PARTICULAR INCIDENT. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS NO FAILURE WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED PHLEBITIS AND AN ABSCESS DURING THE TIME THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS USED. THE PATIENT'S HOSPITALIZATION WAS EXTENDED FOR MONITORING BECAUSE OF THE INCIDENT, HOWEVER NO MEDICAL OR SURGICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313971 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5203334

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization