BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9385770 · Received November 27, 2019

    Report

    Report Number
    9610048-2019-00340
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 13, 2019
    Report Date
    December 20, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE TO BD FOR INVESTIGATION BUT 2 PHOTOS OF THE DEFECT WERE PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 9210542, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS BUT COULD NOT IDENTIFY ANY POSSIBLE DEFECTS THAT COULD LEAD TO LEAKAGE. BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS COULD BE FOUND AND WITHOUT THE PHYSICAL SAMPLE AVAILABLE FOR TESTING A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE ADAPTER AND CATHETER WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AFTER PUNCTURING THE PATIENT IT WAS FOUND THAT PERIPHERAL INTRAVENOUS CATHETER NO. 22 WAS LEAKING, REMOVED AND PUNCTURED BY THE ANESTHETIST. LEAKAGE HAD OCCUR BETWEEN THE ADAPTER AND THE CATHETER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE ADAPTER AND CATHETER WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER PUNCTURING THE PATIENT IT WAS FOUND THAT PERIPHERAL INTRAVENOUS CATHETER NO. 22 WAS LEAKING, REMOVED AND PUNCTURED BY THE ANESTHETIST. LEAKAGE HAD OCCUR BETWEEN THE ADAPTER AND THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182326 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 9210542 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other