BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8241808 · Received January 11, 2019

    Report

    Report Number
    1710034-2018-01005
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8192723; A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AFA LINE 12 FROM 13JUL18 THROUGH 18JUL18. REVIEW OF DHR REVEALED WERE 3 INSTANCES WHERE THE CHALLENGE SAMPLES WERE NOT NOTED AS PASS OR FAIL (REJECT WEDGE CHALLENGE, PLUG DEPTH ATTRIBUTE CHALLENGE AND SPLAY LUBE CHALLENGE), OF WHICH NONE WERE RELATED TO THIS INCIDENT. ALL REQUIRED SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. THESE NON-RECORDED (PASS/FAIL) CHALLENGES ARE BEEN ADDRESSED BY THE QE. REVIEW DISCLOSED ONE NON-RELATED QN WAS INITIATED; DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED AS PER CONTROL PLAN. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. INDETERMINATE: WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THERE WAS AN ISSUE WITH AFTER PRESSING THE BUTTON THE NEEDLE ONLY RETRACTS ABOUT HALFWAY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THERE WAS AN ISSUE WITH AFTER PRESSING THE BUTTON THE NEEDLE ONLY RETRACTS ABOUT HALFWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33396 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8192723 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other