BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW TRAUMA SET: 7 FR

    MDR report key: 9363111 · Received November 22, 2019

    Report

    Report Number
    9680794-2019-00464
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    August 1, 2019
    Report Date
    November 7, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K840455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE EVENT OF THE GUIDE WIRE BEING LEFT IN THE PATIENT WAS LIKELY CAUSED BY THE USER INADVERTENTLY LEAVING THE GUIDE WIRE WHEN REMOVING THE DILATOR. THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER TO REMOVE THE GUIDE WIRE AND DILATOR AS A UNIT. HOWEVER, WITHOUT SUBJECTING THE ACTUAL SAMPLE TO DIMENSIONAL AND FUNCTIONAL TESTING, THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    MEDWATCH (B)(4) RECEIVED IN MORRISVILLE ON NOVEMBER 7, 2019. REPORT INDICATES: A PROCEDURE BY ANESTHESIOLOGIST WAS PERFORMED: INSERTION OF A RAPID INFUSION CATHETER INTO THE LEFT UPPER EXTREMITY USING A GUIDEWIRE. THE PATENCY OF THE IC WAS CHECKED BY ULTRASOUND AND FLUSHED WITH SALINE. THE FOLLOWING DAY, AN EX-RAY THE FOLLOWING CONFIRMED THE GUIDEWIRE WAS RETAINED AND WAS SEEN IN THE LEFT ARM RUNNING ALONG THE LEFT SIDED THORACIC SPINE. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR REMOVAL. PAGE 4 OF MEDWATCH INDICATES OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT WAS THAT THEY HAD DIFFICULTY IN ESTABLISHING IV ACCESS.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). POTENTIAL LOT# 14F19D0018. ATTEMPTS MADE TO OBTAIN ADDITIONAL INFORMATION FROM USER FACILITY. NO RESPONSE FROM USER FACILITY AT THE TIME OF THIS REPORT. A DHR WAS CONDUCTED ON THE POTENTIAL LOT# AND THERE WERE NO RELEVANT FINDINGS.

    Description of Event or Problem · 1

    MEDWATCH 0502280000-2019-8002 RECEIVED IN (B)(6) ON NOVEMBER 7, 2019. REPORT INDICATES: A PROCEDURE BY ANESTHESIOLOGIST WAS PERFORMED: INSERTION OF A RAPID INFUSION CATHETER INTO THE LEFT UPPER EXTREMITY USING A GUIDEWIRE. THE PATENCY OF THE IC WAS CHECKED BY ULTRASOUND AND FLUSHED WITH SALINE. THE FOLLOWING DAY, AN EX-RAY THE FOLLOWING CONFIRMED THE GUIDEWIRE WAS RETAINED AND WAS SEEN IN THE LEFT ARM RUNNING ALONG THE LEFT SIDED THORACIC SPINE. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR REMOVAL. PAGE 4 OF MEDWATCH INDICATES OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT WAS THAT THEY HAD DIFFICULTY IN ESTABLISHING IV ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160052 ARROW TRAUMA SET: 7 FR INTRODUCER, CATHETER DYB ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention