BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DIAGNOTICS PRODUCT

    MDR report key: 4623712 · Received March 23, 2015

    Report

    Report Number
    1282497-2015-00015
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    February 25, 2015
    Report Date
    February 25, 2015
    Manufacturer
    RANFAC CORPORATION
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR POTENTIAL LOT NUMBERS 31060X, 30561X, 29848X. THERE WERE NO MANUFACTURING ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT. NO SAMPLES WERE RECEIVED WITH THIS COMPLAINT THEREFORE AN EXAMINATION COULD NOT BE MADE TO CONFIRM THE REPORTED ISSUE AND DETERMINE THE ROOT CAUSE. AN INVESTIGATION WAS PERFORMED TO DETERMINE A POSSIBLE ROOT CAUSE. BRAZING IS THE PROCESS WHICH ATTACHES THE NEEDLE TO THE HANDLE. ALL POSSIBLE LOTS WERE REVIEWED AND NO ISSUES WERE NOTED DURING BRAZING. IF THE HANDLE WAS SUBJECT TO AN IMPACT FORCE, THE IMPACT FORCE MAY HAVE LED TO A BREAK. EVERY LOT IS TESTED TO EVALUATE THE BRAZED HUB TO CANNULA BOND PRIOR TO RELEASE. NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME SINCE THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF ADDITIONAL INFORMATION OR SAMPLES ARE RECEIVED, THE INVESTIGATION WILL RESUME AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. THE CUSTOMER REPORTED THAT THE PRODUCT ID IS UNKNOWN; HOWEVER, THE PRODUCT ID IS EITHER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A BIOPSY NEEDLE. THE CUSTOMER REPORTS THAT THERE WAS ONLY ONE PATIENT INVOLVED WITH THIS INCIDENT AND THERE WERE A TOTAL OF 4 NEEDLES USED. THE FIRST NEEDLE WORKED FINE, THE 2ND AND 3RD NEEDLES APPEARED TO WORK BUT WOULD NOT UNLOCK AND WOULD GET STUCK AND THEY WOULD NEED TO USE ANOTHER NEEDLE. THE 4TH NEEDLE BROKE OFF AND REMAINED IN THE PATIENT. THE HANDLE DISCONNECTED FROM THE NEEDLE AND THE NEEDLE REMAINED IN THE ILIAC CREST. THE ORTHO TEAM WAS CALLED AND THEY USED LARGE PLIERS TO REMOVE IT. AN X-RAY WAS TAKEN FOR FOREIGN BODY AND WAS CLEAR. THE LEFT SIDE OF THE PROCEDURE WAS ABORTED. THE RIGHT SIDE OF THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192871 UNKNOWN DIAGNOTICS PRODUCT BIOPSY NEEDLE KNW RANFAC CORPORATION UNK DI

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR