BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROCKENBROUGH¿ NEEDLE

    MDR report key: 8510636 · Received April 12, 2019

    Report

    Report Number
    9612164-2019-01311
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    April 11, 2019
    Report Date
    March 17, 2020
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DRC
    UDI-DI
    00613994663146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE TRANSSEPTAL NEEDLE, (B)(4) WITH LOT NUMBER 215947562, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE NEEDLE SHOWED THAT NO ISSUE WAS IDENTIFIED. THE REPORTED SKIVING ISSUE COULD NOT BE CONFIRMED THROUGH TESTING; HOWEVER, IT IS PLAUSIBLE THAT SKIVING OCCURRED AS THERE IS A COMPATIBILITY ISSUE WITH THE NEEDLE AND A COMPETITOR SHEATH. THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE BROCKENBROUGH NEEDLE, EP003994S WITH LOT NUMBER 215947562, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE NEEDLE SHOWED THAT NO ISSUE WAS IDENTIFIED. THE REPORTED SKIVING ISSUE WAS NOT CONFIRMED THROUGH VISUAL INSPECTION OF THE PRODUCT. THE NEEDLE PASSED THE RETURNED PRODUCT INSPECTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 990061-070, LOT#: C1-13038. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION FOR AN RADIOFREQUENCY (RF) PROCEDURE, THE NEEDLE "SHAVED" THE INSIDE OF THE SHEATH. THE PRODUCTS WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302564 BROCKENBROUGH¿ NEEDLE TROCAR DRC MEDTRONIC MEXICO EP003994S 215947562 00613994663146

    Patients

    Seq Age Sex Outcome Treatment
    1