BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7635245 · Received June 25, 2018

    Report

    Report Number
    1710034-2018-00357
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 5, 2018
    Report Date
    September 7, 2018
    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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELD: DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE DEVICE HISTORY REPORT FOR LOT NUMBER 8051797 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER 382533 FOR LOT 8051797 WAS MANUFACTURED 02/26/2018 - 03/02/2018. THIS IS THE FIRST INSTANCE OF THIS FAILURE MODE WITH THIS LOT NUMBER. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. ADDITIONALLY A PHOTOGRAPH AND PHYSICAL SAMPLE WERE SUBMITTED FOR THE PURPOSE OF AIDING OUR QUALITY ENGINEER IN THEIR INVESTIGATION. THROUGH THE VISUAL/MICROSCOPIC EXAMINATION THE CATHETER-ADAPTER ASSEMBLY DID NOT DISPLAY ANY FOREIGN MATERIAL HOWEVER A PARTICLE OF WHITE-CLEAR MATERIAL WAS ATTACHED TO THE TOP WEB STRIP. THE FOREIGN MATTER OBSERVED ON THE CATHETER TUBING WAS CONFIRMED TO BE NON-FOREIGN (PLUG SHAVINGS) WHICH RESULTED FROM MANUFACTURING DURING THE ASSEMBLY PROCESS. INVESTIGATION CONCLUSION: FOREIGN MATTER CAN BE LOOSELY ATTACHED TO THE CATHETER TUBING DUE TO THE SILICONE LUBE. THE FM OBSERVED ON THE TIP OF THE CATHETER TUBING WAS CONFIRMED TO BE NON-FOREIGN (POROUS PLUG SHAVINGS) AND TO HAVE RESULTED FROM MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS ¿A PIECE OF MATERIAL¿) WAS FOUND ON THE END OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS ¿A PIECE OF MATERIAL¿) WAS FOUND ON THE END OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS ¿A PIECE OF MATERIAL¿) WAS FOUND ON THE END OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475229 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8051797 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other