BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 5108634 · Received September 28, 2015

    Report

    Report Number
    1710034-2015-00013
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    February 18, 2014
    Report Date
    September 24, 2015
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS NEITHER A CATALOG NOR A LOT NUMBER FOR THIS INCIDENT WAS PROVIDED. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A COLONOSCOPY ON (B)(6) 2014, A BD INSYTE UTOGUARD SHIELDED IV CATHETER WAS PLACED IN A PATIENT'S RIGHT ARM. WHILE THE NURSE WAS PERFORMING THE IV INSERTION, THE PATIENT HEARD A "SNAP". THE NURSE EXCUSED HERSELF WITHOUT FINISHING THE IV INSERTION AND STATED THAT SHE NEEDED A NEW IV BECAUSE THIS ONE WAS GIVING HER TROUBLE. A SECOND NURSE CAME BACK TO THE PATIENT AND SUCCESSFULLY INSERTED A NEW IV. THE PATIENT RECEIVED HIS COLONOSCOPY, WHICH WENT SMOOTHLY, AND THE PATIENT WAS DISCHARGED TO HOME. A FEW DAYS LATER, THE PATIENT DEVELOPED REDNESS, SWELLING, ITCHING, AND LATER NOTICED THAT WHEN HE BENT HIS ARM HE COULD FEEL A PRICK OF SOMETHING IN HIS ARM AT THE LOCATION WHERE THE FIRST IV WAS ATTEMPTED. THE PATIENT WENT BACK TO THE PHYSICIAN THAT PERFORMED THE COLONOSCOPY AND RECEIVED X-RAYS OF HIS ARM AND WAS TOLD THAT THE X-RAYS DID NOT SHOW A RETAINED FOREIGN OBJECT. THE PATENT CONTINUED TO FEEL A "POKING" SENSATION IN HIS ARM SO HE HAD AN ULTRASOUND DONE WHICH CONFIRMED THE PRESENCE OF A FOREIGN BODY IN HIS ARM. THE PATIENT WAS THEN EVALUATED BY TWO VASCULAR SURGEONS AND HIS DERMATOLOGIST. THE SECOND VASCULAR SURGEON PERFORMED A SECOND ULTRASOUND WHICH AGAIN CONFIRMED A RETAINED FOREIGN BODY. ON (B)(6) 2014, THE PATIENT HAD SURGERY TO REMOVE THE BROKEN IV CATHETER FROM THE VEIN IN HIS RIGHT ARM. ADDITIONALLY, THE PATIENT HAS REPORTED THAT HE CURRENTLY HAS NO FEELING IN HIS ARM RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638787 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention