BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NYL BLK MONO

    MDR report key: 7105393 · Received December 11, 2017

    Report

    Report Number
    2210968-2017-71704
    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). CORRECTED SUMMARY: AN EMPTY OPENED OVERWRAP, A LABELED WINDING FORMER WITH A NEEDLE/SUTURE PARTIALLY DISPENSED WAS RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE OPENED SAMPLE, THE INFORMATION OF PRODUCT CODE, LOT NUMBER AND GRAPHIC ON THE LABEL OVERWRAP AND PAPER LID PRINTED WAS COMPARED WITH US THUNDERBIRD SYSTEM AND ARE CORRECT. AS THE GRAPHICS OF THE CODE WERE UPDATED ON 2016 FROM NEEDLE 3/8 CIRCLE TO 1/4 CIRCLE AND AS THE LOT LDH092 WAS MADE 4/18/2017 NO DISCREPANCIES OR ISSUES WERE NOTED. DUE TO THE SAMPLE CONDITION, NO DEFECTS WERE FOUND AT THE INFORMATION ON THE BOX AS IS CORRECT ACCORDING TO OUR SYSTEM. REPRESENTATIVE SAMPLE WAS RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE OPENED SAMPLE, NO DEFECTS WERE OBSERVED. THE INFORMATION OF PRODUCT CODE, LOT NUMBER AND GRAPHIC ON THE LABEL OVERWRAP AND PAPER LID PRINTED WAS COMPARED WITH US THUNDERBIRD SYSTEM AND ARE CORRECT. AS THE GRAPHICS OF THE CODE WERE UPDATED ON 2016 FROM NEEDLE 3/8 CIRCLE TO 1/4 CIRCLE AND AS THE LOT LDH092 WAS MADE 4/18/2017 NO DISCREPANCIES OR ISSUES WERE NOTED. DUE TO THE SAMPLE CONDITION, NO DEFECTS WERE FOUND AT THE INFORMATION ON THE SAMPLE AS IS CORRECT ACCORDING TO OUR SYSTEM.

    Additional Manufacturer Narrative · 1

    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 (B)(4) OR OUTSIDE (B)(4)? 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

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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 AN EMPTY OPENED OVERWRAP, A LABELED WINDING FORMER WITH A NEEDLE/SUTURE PARTIALLY DISPENSED WAS RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE OPENED SAMPLE, THE INFORMATION OF PRODUCT CODE, LOT NUMBER AND GRAPHIC ON THE LABEL OVERWRAP AND PAPER LID PRINTED WAS COMPARED WITH US THUNDERBIRD SYSTEM AND ARE CORRECT. AS THE GRAPHICS OF THE CODE WERE UPDATED ON 2016 FROM NEEDLE 3/8 CIRCLE TO 1/4 CIRCLE AND AS THE LOT KDZ665 WAS MADE 4/18/2017 NO DISCREPANCIES OR ISSUES WERE NOTED. DUE TO THE SAMPLE CONDITION, NO DEFECTS WERE FOUND AT THE INFORMATION ON THE BOX AS IS CORRECT ACCORDING TO OUR SYSTEM. REPRESENTATIVE SAMPLE WAS RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE OPENED SAMPLE, NO DEFECTS WERE OBSERVED. THE INFORMATION OF PRODUCT CODE, LOT NUMBER AND GRAPHIC ON THE LABEL OVERWRAP AND PAPER LID PRINTED WAS COMPARED WITH US THUNDERBIRD SYSTEM AND ARE CORRECT. AS THE GRAPHICS OF THE CODE WERE UPDATED ON 2016 FROM NEEDLE 3/8 CIRCLE TO 1/4 CIRCLE AND AS THE LOT LDH092 WAS MADE 4/18/2017 NO DISCREPANCIES OR ISSUES WERE NOTED. DUE TO THE SAMPLE CONDITION, NO DEFECTS WERE FOUND AT THE INFORMATION ON THE SAMPLE AS IS CORRECT ACCORDING TO OUR SYSTEM.

    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
    884056 NYL BLK MONO SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. LDH092

    Patients

    Seq Age Sex Outcome Treatment
    1