BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR BIOPSY PROBE

    MDR report key: 8647250 · Received May 28, 2019

    Report

    Report Number
    2020394-2019-00611
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    April 27, 2019
    Report Date
    December 23, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086243
    PMA / PMN Number
    K040842
    Removal / Correction Number
    Z-2211-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER NOTIFICATION WAS ISSUED FOR THE ENCOR BREAST BIOPSY PROBE FOR SPECIFIC PRODUCT CODE/LOT NUMBER COMBINATIONS. THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS MAY BE AT RISK OF EXPERIENCING A LEAK BETWEEN THE PROBE AND THE TISSUE COLLECTION CHAMBER, WHICH COULD RESULT IN MINIMAL SUCTION, LEAKAGE, MINIMAL OR NO TISSUE SAMPLE OBTAINED, OR AN EGRESS OF FLUIDS FROM THE DEVICE. A ROOT CAUSE INVESTIGATION AND FIELD ACTION DETERMINATION WAS CONDUCTED AS A RESULT OF AN INCREASE IN COMPLAINTS FOR LEAKS, SUCTION ISSUES, AND FAILURE TO OBTAIN SAMPLES. THE INVESTIGATION INCLUDED AN EXTENSIVE MANUFACTURING REVIEW, RISK DOCUMENTATION REVIEW FOR THE THREE REPORTED MALFUNCTIONS, AND EVALUATIONS PERFORMED ON THE RETURNED DEVICES. THE INVESTIGATION IDENTIFIED THAT ONE OF THE FEATURES ON THE TRAP CHAMBER WAS UNDER SPECIFIED AND DURING THE IMPLEMENTATION OF A NEW TRAP CHAMBER (DC2448) MOLD, ONE OF THE DIMENSIONS CHANGED AND WENT UNDETECTED, CREATING A DIFFERENCE BETWEEN THE AMOUNT OF SPACE THAT THE SEAL HAS BETWEEN THE TRAP CHAMBER AND THE FRONT SEAL CAP. THIS GAP BETWEEN THE TRAP CHAMBER AND FRONT SEAL CAP RESULTED IN CONDITIONS THAT LED TO A HIGHER LIKELIHOOD OF LEAKS, SUCTION ISSUES, AND FAILURE TO OBTAIN SAMPLES. ALL REPORTED COMPLAINTS FROM THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS THAT ARE POSSIBLY RELATED TO THE GAP BETWEEN THE TRAP CHAMBER AND FRONT SEAL CAP HAVE BEEN CLASSIFIED AS LEAK, SUCTION ISSUES), OR FAILURE TO OBTAIN SAMPLES. THIS REPORTED COMPLAINT IS FROM AN AFFECTED LOT NUMBER THAT WAS REPORTED FOR ONE OF THESE TRAP CHAMBER ISSUES. (EXPIRATION DATE: 07/2020), (DEVICE COMPONENT CODE: 432) .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE DEVICE ALLEGEDLY HAD A SUCTION ISSUE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED AS A REPORTABLE MALFUNCTION FOR THE SPECIAL CAUSE RELATED TO THESE PRODUCT CATALOG/LOT NUMBER COMBINATIONS WHICH IS THE SUBJECT OF REPORT OF CORRECTIONS AND REMOVAL LETTER (806 NOTIFICATION) ON MAY 2, 2019. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 11/2020), ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE DEVICE ALLEGEDLY HAD A SUCTION ISSUE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440929 ENCOR BIOPSY PROBE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. ECP0110G VTCY0547 00801741086243

    Patients

    Seq Age Sex Outcome Treatment
    1