BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16G X 10CM MAGNUM NEEDLE

    MDR report key: 5006902 · Received July 28, 2015

    Report

    Report Number
    2020394-2015-01186
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FCG
    PMA / PMN Number
    K934370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER CLINICAL REVIEW OF THIS EVENT WITH BARD'S MEDICAL DEPARTMENT, THIS EVENT WAS REASSESSED AND DETERMINED TO BE MDR REPORTABLE AS A SERIOUS INJURY PURSUANT TO 21 CFR PART 803. A MANUFACTURING REVIEW WAS CONDUCTED AND THE REPORTED LOT MET ALL RELEASE CRITERIA. THE MAGNUM BIOPSY NEEDLE WAS RETURNED INSIDE OF A COAXIAL NEEDLE. IT WAS NOTED THAT A WIRE FRAGMENT WAS LODGED BETWEEN THE SAMPLE NOTCH AND THE CANNULA, CAUSING THE TIP OF THE STYLET TO APPEAR TO BE BENT. THE WIRE FRAGMENT COULD NOT BE EASILY REMOVED AS IT WAS TWISTED AROUND THE TIP OF THE SAMPLE NOTCH. ONCE WIRE WAS REMOVED, THE NEEDLE MOVED FREELY AND NO ANOMALIES NOTED ON THE NEEDLE. THE WIRE PIECE WAS EXAMINED UNDER MICROSCOPE; IT WAS CYLINDRICAL AND RESEMBLED A STAPLE. THE INVESTIGATION IS UNCONFIRMED FOR BENT NEEDLE, AS THE NEEDLE WAS WITHIN SPECIFICATION. IT APPEARS AS PROCEDURAL FACTORS COULD BE POTENTIALLY RELATED TO THE REPORTED BENT NEEDLE, HOWEVER, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: THIS PRODUCT SHOULD BE USED BY A PHYSICIAN WHO IS COMPLETELY FAMILIAR WITH THE INDICATIONS, CONTRAINDICATIONS, LIMITATIONS, TYPICAL FINDINGS AND POSSIBLE SIDE EFFECTS OF CORE NEEDLE BIOPSY. NEVER TEST THE INSTRUMENT WHILE THE NEEDLE IS INSTALLED IN THE INSTRUMENT. THIS COULD RESULT IN NEEDLE DAMAGE AND/OR PATIENT/USER INJURY. INSPECT THE INSTRUMENT FOR SIGNS OF DETERIORATION OR DAMAGE. DO NOT USE IF THE NEEDLE COMPONENTS ARE DAMAGED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE ON THE SECOND SAMPLE ACQUISITION, THE NEEDLE WAS DIFFICULT TO REMOVE FROM THE COAXIAL AND THE PHYSICIAN HAD TO WIDEN THE INCISION IN ORDER TO REMOVE THE COAXIAL AND THE NEEDLE TOGETHER. WHEN THE NEEDLE AND COAXIAL WERE REMOVED FROM THE PATIENT, IT WAS DISCOVERED THAT THE NEEDLE WAS BENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491179 16G X 10CM MAGNUM NEEDLE FCG BARD PERIPHERAL VASCULAR, INC. REXB0192

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention