BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8302845 · Received February 4, 2019

    Report

    Report Number
    1710034-2019-00139
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 8, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER WAS UNABLE TO CONFIRM THE LOT NUMBER, HOWEVER THE CUSTOMER PROVIDED 4 LOT NUMBERS: REVIEW OF ALL THE DHR'S SHOWED NO QUALITY NOTIFICATIONS AND THE FINISH PRODUCT TESTING RESULTS WERE ALL PASSED PER SPECIFICATIONS. RECEIVED A TOTAL OF 4 UNITS OF WHICH 3 WERE WITHIN SEALED PACKAGES FROM LOTS 8275535, 8100635, AND 8134857 (1 EA.) AND 1 WAS RECEIVED WITHIN A PARTIALLY OPEN PACKAGE FROM LOT NUMBER 7293637. ALL CONTENTS WITHIN WERE INTACT. VISUAL EXAMINATION: NO DAMAGE WAS OBSERVED ON ANY AREAS THE PACKAGE RECEIVED. THE SEAL OF THE PACKAGE WAS ACCEPTABLE PER SPECIFICATIONS AND STERILITY WAS NOT COMPROMISED. WATER-LEAK TEST: THE WATER LEAK WAS PERFORMED ON THE RECEIVED PACKAGES (SEALED PACKAGES ONLY, NO LEAKAGE WAS OBSERVED ON ANY AREA. OPEN PACKAGE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL WIDTH WITH ADHESIVE TRANSFER FROM THE TOP WEB PAPER TO THE BOTTOM WEB FILM. THIS CHARACTERISTIC WAS MET. THE KEY VARIABLES THAT AFFECT THE PACKAGING SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, AND THE FAILURE DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE REPLICATED AT THE LABORATORY. THE ACTUAL UNIT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INFANT PATIENT DEVELOPED MRSA IN THE BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER PUNCTURE SITE 24 HOURS AFTER REMOVAL. THE PATIENT WAS REPORTED TO HAVE BEEN "PLACED IN ISOLATION" AND RECEIVED ANTIBIOTICS FOR TREATMENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFANT PATIENT DEVELOPED (B)(6) IN THE BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER PUNCTURE SITE 24 HOURS AFTER REMOVAL. THE PATIENT WAS REPORTED TO HAVE BEEN "PLACED IN ISOLATION" AND RECEIVED ANTIBIOTICS FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95653 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention