BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WITH BD VIALON¿

    MDR report key: 5147918 · Received October 14, 2015

    Report

    Report Number
    1710034-2015-00014
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 18, 2015
    Report Date
    November 12, 2015
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS 5026779, 5156736 AND 5191759. ONE USED SAMPLE FROM AN UNKNOWN LOT NUMBER AND THREE EMPTY PACKAGES FROM THE LOT NUMBERS 5026779, 5156736 AND 5191759 WERE RECEIVED FOR EVALUATION. USING A LAB SUPPLIED CATHETER/ADAPTER SAMPLE, THE LENGTH WAS COMPARED TO THE RETURNED SAMPLE. A VISUAL/MICROSCOPIC EXAMINATION OF THE USED SAMPLE OBSERVED APPROXIMATELY HALF OF THE CATHETER TUBING WAS MISSING. THE TUBING EDGES WERE CLEAN, JAGGED WITH VERY LITTLE STRINGS/FLASHING. CONCLUSION - THE DEFECT WAS CONFIRMED. THE CATHETER/ADAPTER ASSEMBLY DEMONSTRATED EVIDENCE OF HAVING BEEN CUT WITH A SHARP INSTRUMENT. WITH THE SAMPLE AND INFORMATION PROVIDED, IT CANNOT BE DETERMINED HOW OR WHEN THIS TYPE OF DAMAGE OCCURRED. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THREE LOT NUMBERS WERE SUPPLIED BY CUSTOMER AS THEY ARE UNSURE WHICH DEVICE WAS USED IN THIS INCIDENT - POTENTIAL LOT # 5191759, 5156736, AND 5026779. PHOTOS OF THE DEVICE ARE AVAILABLE. A SAMPLE OF THE DEVICE IS AVAILABLE AND HAS BEEN SENT BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. A QUALITY NOTIFICATION REVIEW INDICATES NO QUALITY NOTIFICATIONS GENERATED FOR LOT 5191759, 5156736, OR 5026779. PHOTOS AVAILABLE FOR EVALUATION. A SAMPLE WAS RECEIVED 10/9/15.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF A BD INSYTE AUTOGUARD SHIELDED IV CATHETER, A PORTION OF THE CATHETER SPLINTERED OFF AND REMAINED IN THE PATIENT'S VEIN. THE PATIENT RECEIVED A LEFT HUMERUS AND 2-VIEW CHEST X-RAY. THE CARDIOLOGIST DISCUSSED THE RESULTS WITH THE PATIENT AND THE DECISION WAS MADE NOT TO REMOVE THE BROKEN CATHETER. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH HIS/HER PRIMARY CARE PHYSICIAN IF ANY ADVERSE SYMPTOMS APPEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679739 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WITH BD VIALON¿ SHIELDED IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention