BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR BIOPSY PROBE, UPRIGHT

    MDR report key: 4993277 · Received August 6, 2015

    Report

    Report Number
    2020394-2015-01304
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Report Date
    July 7, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K040842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED AND THE REPORTED LOT MET ALL RELEASE CRITERIA. VISUAL/MICROSCOPIC INSPECTION: THE PROBE WAS RETURNED SEALED IN THE ORIGINAL PACKAGING. THE PROBE WAS EXAMINED THROUGH THE BACK OF THE CLEAR PLASTIC TRAY, AND THE SAMPLE CHAMBER WAS FOUND TO NOT CONTAIN TUBING WITHIN THE SAMPLE CHAMBER, INDICATING THAT THE SAMPLE CHAMBER WAS FOR A NON-UPRIGHT PROBE. IN ADDITION, THERE WAS NO TRAY COVER NOTED ON THE SAMPLE TRAY, INDICATING THE TRAY WAS FOR A NON-UPRIGHT PROBE. HOWEVER, THE EXTRA SAMPLE TRAY WITHIN THE PACKAGING DID CONTAIN A TRAY COVER. NO ANOMALIES WERE NOTED TO THE PROBE OR PACKAGING. FUNCTIONAL/PERFORMANCE EVALUATION:DUE TO THE REPORTED FAILURE, FUNCTIONAL TESTING WAS UNNECESSARY. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: TWO ELECTRONIC PHOTOS WERE RETURNED IN AN ATTACHED EMAIL. THE FIRST PHOTO SHOWS AN ENCOR PROBE LABELING, INDICATING CATALOG NUMBER ECP0110GV AND LOT NUMBER VT14L03896. THE LABELING IS MARKED AS AN UPRIGHT DEVICE. THE SECOND PHOTO SHOWS THE UNDERSIDE OF AN ENCOR PROBE TRAY. THE PROBE, TUBING, EXTRA SAMPLE TRAY, AND ANESTHETIC SYRINGE ARE VISIBLE THROUGH THE CLEAR PLASTIC TRAY. HOWEVER, BASED ON THE PHOTOS RETURNED THE ALLEGED MISLABELING CANNOT BE CONFIRMED. CONCLUSION: ALTHOUGH THE ALLEGED MISLABELING COULD NOT BE CONFIRMED BASED ON THE RETURNED PHOTOS, THE INVESTIGATION IS CONFIRMED FOR THE ALLEGED MISLABELING, AS THE RETURNED SAMPLE CHAMBER WAS NOT AN UPRIGHT SAMPLE CHAMBER, AND THEREFORE DID NOT MATCH THE LABELING. BASED ON THE INVESTIGATION PERFORMED AT THE MANUFACTURING SITE (INFUS), THE COMPONENT MIX-UP MOST LIKELY OCCURRED DURING THE MANUFACTURE/FUNCTIONAL TESTING. AN INTERNAL INVESTIGATION WAS INITIATED TO IDENTIFY ANY APPLICABLE CORRECTIVE AND/OR PREVENTATIVE ACTIONS. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: COMPLICATIONS: COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF THE ENCOR® BIOPSY DEVICE AND DRIVER ARE THE SAME AS THOSE ASSOCIATED WITH THE USE OF OTHER BIOPSY DEVICES. THESE MAY INCLUDE INJURY TO THE SKIN, BLOOD VESSELS, MUSCLES, ORGANS, BLEEDING, HEMATOMA AND INFECTION. DIRECTIONS FOR USE: INSPECT THE PACKAGE TO INSURE THAT THE PACKAGE INTEGRITY HAS NOT BEEN COMPROMISED. THE PRODUCT IS STERILE UNLESS THE SEAL IS BROKEN. USING STANDARD ASEPTIC TECHNIQUE, REMOVE THE BIOPSY PROBE FROM THE PACKAGE AND CHECK FOR DAMAGE. TO USE THE SAMPLE RINSE FEATURE, ATTACH THE VACUUM TUBE CONNECTOR, AND THE RINSE TUBE CONNECTOR, TO THE VACUUM UNIT. INSTALL THE BIOPSY DEVICE TO THE DRIVER BY SLIDING THE DISTAL END INTO PLACE AND THEN PRESSING DOWN ON THE PROXIMAL END TO LOCK. REMOVE THE COVER FOR STEREOTACTIC USE. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFO, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PREPARATION FOR A VERTICAL BREAST BIOPSY, THE PROBE LABEL IDENTIFIED THE PROBE AS A VERTICAL PROBE AND INSIDE THE PACKAGE IT WAS A STANDARD/LATERAL PROBE. ANOTHER PROBE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520526 ENCOR BIOPSY PROBE, UPRIGHT KNW BARD PERIPHERAL VASCULAR, INC. VT14L0386

    Patients

    Seq Age Sex Outcome Treatment
    1