BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NYL BLK MONO

    MDR report key: 7105427 · Received December 11, 2017

    Report

    Report Number
    2210968-2017-71707
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 23, 2017
    Report Date
    November 24, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CONFIRM WHAT DO YOU MEAN BY "THE CODE 644H IS REGISTERED AS A 3/8 CIRCLE BUT ABOVE THE "DECODER SUTURE" TOOL BUT ABOVE THE PACKAGING THERE IS WRITTEN 1/4C."? WAS IT A PACKAGE LABELLING ISSUE? OR ERROR WITH CHANGES /UPDATES TO PACKAGING/DESIGN ETC? WAS IT NOTICED ON THE OUTER BOX OR INNER PACKAGE? WAS THE BOX OPENED TO CHECK IF THE COMPONENTS INSIDE WERE CORRECT AS PER REGISTER? WHEN WAS THIS ISSUE NOTICED? WITHIN J&J CONTROL OR OUTSIDE J&J CONTROL? WAS THIS DISCOVERED AT THE DISTRIBUTOR OR AT A HOSPITAL OR SIMILAR FACILITY? IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? IS THERE ANY INDICATION OF THE SOURCE? BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE PRODUCT MAY HAVE COME FROM? DO YOU HAVE ANY PICTURES OF THE PACKAGE WITH THIS ISSUE?

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 02/07/2018 NO SUTURE, NEEDLE OR WINDING FORMER WERE RETURNED FOR EVALUATION TO DETERMINE THE ASSIGNABLE CAUSE OF THE PACKAGING - LABELING IDENTIFICATION; THEREFORE, THE REPORTED FAILURE COULD NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # PC-(B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM WHAT DO YOU MEAN BY "THE CODE 644H IS REGISTERED AS A 3/8 CIRCLE BUT ABOVE THE "DECODER SUTURE" TOOL BUT ABOVE THE PACKAGING THERE IS WRITTEN 1/4C."? THE DISTRIBUTED PACKAGING REPORTS THE DESCRIPTION OF THE CURVE OF THE NEEDLE 1/4 ALTHOUGH IN THE PAST IT WAS 3/8 AS REGISTERED ALSO IN THE MARKETING TOOL. WAS IT A PACKAGE LABELLING ISSUE? THE NEEDLE CURVE IS DIFFERENT (1/4 THE ONE DELIVERED, IN THE PAST IT WAS 3/8 AND THIS SAME 3/8 IS REPORTED ONTO THE MARKETING MATERIAL). OR ERROR WITH CHANGES /UPDATES TO PACKAGING/DESIGN ETC? WAS IT NOTICED ON THE OUTER BOX OR INNER PACKAGE? BOTH. WAS THE BOX OPENED TO CHECK IF THE COMPONENTS INSIDE WERE CORRECT AS PER REGISTER? THE DEVICE WAS OPENED BY THE SURGEON THAT NOTICED THE DISCREPANCY. WHEN WAS THIS ISSUE NOTICED? WITHIN J&J CONTROL OR OUTSIDE J&J CONTROL? INTO THE HOSPITAL. WAS THIS DISCOVERED AT THE DISTRIBUTOR OR AT A HOSPITAL OR SIMILAR FACILITY? HOSPITAL. IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? UNK . IS THERE ANY INDICATION OF THE SOURCE? UNK. BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE PRODUCT MAY HAVE COME FROM? UNK. DO YOU HAVE ANY PICTURES OF THE PACKAGE WITH THIS ISSUE? YES, ATTACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. IT WAS NOTED THAT THE PRODUCT CODE WAS REGISTERED AS A 3/8 CIRCLE BUT ABOVE THE "DECODER SUTURE" TOOL BUT ABOVE THE PACKAGING THERE IS WRITTEN 1/4C. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884427 NYL BLK MONO SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. KGH075

    Patients

    Seq Age Sex Outcome Treatment
    1