BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA

    MDR report key: 9763790 · Received February 27, 2020

    Report

    Report Number
    3011137372-2020-00074
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    February 19, 2020
    Report Date
    February 19, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FCG
    PMA / PMN Number
    K113872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE MANUFACTURING DHR FILE WAS REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. RECEIVED ONE (1) 5.250 INCHES SECTION OF BIOPSY CANNULA, 13GA X 147MM, FROM PRODUCT CODE 9464-VC-0067. AT VISUAL INSPECTION HEAVY DAMAGE TO THE CANNULA HUB END AND DISTAL TIP END WAS WITNESSED. DEFECT SAMPLE ANALYSIS AND INVESTIGATION HAS CONFIRMED THE STATED DEFECT REPORT. HOWEVER, AFTER CAREFUL REVIEW OF THE SAMPLE, AND A THOROUGH REVIEW OF THE RED STAR MANUFACTURING DHR, A CONCLUSIVE ROOT CAUSE ASSIGNMENT FOR THE DEFECT CANNOT BE DETERMINED. IT WAS DETERMINED THAT THE SINGLE ACTUAL COMPLAINT WAS BILL OF MATERIALS ITEM NUMBER 7127 BASED ON THE OVERALL LENGTH AND DEPTH MARKINGS; IT WAS CONCLUDED THAT THE 'HUB' OF THE SINGLE ACTUAL COMPLAINT SAMPLE WAS DAMAGED/REMOVED DURING THE PROCEDURE THAT WAS REQUIRED TO REMOVE THE DEVICE FROM THE PATIENTS HIP BONE, USING THE "LARGER ORTHO DRILL" AS DESCRIBED BY THE CUSTOMER. THE TWO (2) 9401 ONCONTROL POWER DRIVERS RETURNED ALONG WITH THE SINGLE ACTUAL COMPLAINT SAMPLE WERE RECEIVED WITH THE LED'S BLINKING RED AND WITH DAMAGE TO THE DISTAL TIP RUBBER SHAFT SEALS. BOTH DRIVERS PASSED THE TEST INSPECTION CRITERIA AT TELEFLEX (MORRISVILLE). THE ROOT CAUSE OF THE EVENT COULD NOT BE ESTABLISHED, IT COULD ALSO NOT BE DETERMINED IF EITHER DRIVER CONTRIBUTED TO THE EVENT. TELEFLEX WILL CONTINUE TRENDING FOR LIKE DEFECTS AND WILL REPORT ACCORDINGLY SHOULD A SPIKE IN DEFECTS OCCURS. CERTIFICATE OF COMPLIANCE, ENGINEERING REPORT MEMORANDUM, DHR REVIEW RESULTS, AND PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ON THE TABLE AND THE NEEDLE WAS STUCK IN THE BONE AND THEY COULD NOT GET IT OUT. THE ACCOUNT ENDED UP GETTING ORTHO TO COME OUT AND GET THE NEEDLE OUT. ADDITIONAL INFORMATION FROM THE PHYSICIAN INDICATES THE PATIENT SUFFERED NO ADVERSE EFFECTS FROM THE BROKEN NEEDLE. WE WERE ABLE TO HAVE THE ORTHOPEDIC SURGEON ASSIST US DURING THE PROCEDURE AND BORE OUT THE BONE AROUND THE BROKEN ONCONTROL NEEDLE USING A LARGER ORTHOPEDIC DRILL. THE NEEDLE CAME OUT EASILY. THE BONE LESION BEING BIOPSIED WAS IN THE L ILIAC BONE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ON THE TABLE AND THE NEEDLE WAS STUCK IN THE BONE AND THEY COULD NOT GET IT OUT. THE ACCOUNT ENDED UP GETTING ORTHO TO COME OUT AND GET THE NEEDLE OUT. ADDITIONAL INFORMATION FROM THE PHYSICIAN INDICATES THE PATIENT SUFFERED NO ADVERSE EFFECTS FROM THE BROKEN NEEDLE. WE WERE ABLE TO HAVE THE ORTHOPEDIC SURGEON ASSIST US DURING THE PROCEDURE AND BORE OUT THE BONE AROUND THE BROKEN ONCONTROL NEEDLE USING A LARGER ORTHOPEDIC DRILL. THE NEEDLE CAME OUT EASILY. THE BONE LESION BEING BIOPSIED WAS IN THE L ILIAC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227914 ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA BIOPSY NEEDLE KIT FCG TELEFLEX MEDICAL 37581316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention