BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8324404 · Received February 8, 2019

    Report

    Report Number
    1710034-2019-00163
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 7, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814115
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR - THE LOT NUMBER WAS BUILT ON AFA LINE 4 FROM 25JUN2017 THRU 27JUN2017. PACKAGED ON PACKAGING LINE 11 ON 01JUL2017. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. THE FINISH PRODUCT TESTING RESULTS ITEMS PASSED PER SPECIFICATIONS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. RECEIVED A 24GA UNIT WITHIN A SEALED PACKAGE FROM LOT: 7170679. ALL CONTENTS WITHIN WERE INTACT. VISUAL EXAMINATION: NO DAMAGE WAS OBSERVED ON 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 PACKAGE, NO LEAKAGE WAS OBSERVED ON ANY AREA. INDETERMINATE: THE RETURNED UNIT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INFANT DEVELOPED MRSA AT THE IV SIT FROM WHERE A 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS REMOVED. "BABY DEVELOPED MRSA IN IV SITE 24 HOURS AFTER REMOVAL."

    Additional Manufacturer Narrative · 1

    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 AN INFANT DEVELOPED (B)(6) AT THE IV SIT FROM WHERE A 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS REMOVED. "BABY DEVELOPED (B)(6) IN IV SITE 24 HOURS AFTER REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117255 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7170679 30382903814115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention