BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERS GR BRD

    MDR report key: 7400161 · Received April 5, 2018

    Report

    Report Number
    2210968-2018-71925
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    January 1, 2018
    Report Date
    March 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. REPRESENTATIVE SAMPLES WERE RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF SAMPLE, NO DEFECTS WERE FOUND ON THE PACKAGE. THE SAMPLE WAS OPENED AND THE SWAGE AND ATTACHMENT AREA OF THE NEEDLE WERE AS EXPECTED. THE SUTURE WAS DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS WERE OBSERVED. THE SAMPLE WAS TESTED BY NEEDLE PULL AND MEET THE FINISHED GOODS REQUIREMENTS. PER THE CONDITIONS OF THE SAMPLE RECEIVED, NO ATTACHMENT DEFECTS WERE FOUND AND THE TESTED SAMPLE MET THE FINISHED GOODS REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DISPENSED FROM THE THREAD AS IT PASSED THROUGH THE TISSUE. NO PIECE OF THE NEEDLE FELL INSIDE OF THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242823 MERS GR BRD SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. LKP992

    Patients

    Seq Age Sex Outcome Treatment
    1