BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 6650256 · Received June 19, 2017

    Report

    Report Number
    2210968-2017-32635
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Report Date
    June 6, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THE PHOTO OF THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION OF THE PHOTO IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: LOT NUMBER INVOLVED - THE LOT NO. IS KLQ 624. THE PICTURE IS ALSO ATTACHED IN THIS E-MAIL. THERE¿S NO PICTURE OF WHITE SUTURE AT THE MOMENT. PHOTO OF WHITE SUTURE - THERE¿S NO PICTURE OF THE WHITE SUTURE SINCE IT¿S BEING DISCARDED BY THE CUSTOMER. PLEASE PROVIDE STORAGE CONDITIONS OF THE SUTURE - THE PRODUCT STORED NORMALLY IN THE HOSPITAL STOCK IN THE ROOM TEMPERATURE 25 C. WAS THE PRODUCT RE-STERILIZED? - BECAUSE THE COMPLAINT PRODUCT IS BEING DISCARDED BY THE CUSTOMER. IT¿S NOT RE-STERILIZED.

    Additional Manufacturer Narrative · 1

    AN EMPTY OPENED BOX, A SEALED BOX AND OPENED SAMPLES WERE RETURN FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGE THE SAMPLES WERE OPENED AND THE NEEDLES WERE ATTACHED TO THE SUTURES. THE CHANNEL AREA OF THE NEEDLE/SUTURE WAS EXAMINED FOR VISUAL INSPECTION ATTRIBUTE DEFECTS AND NO ATTACHMENT DEFECTS WERE NOTED. THE SUTURES WERE DISPENSED AND EXAMINED PER APPEARANCE AND COLOR ALONG OF THE STRAND AND NOT DEFECTS WERE FOUND. THE INFORMATION OF THE PRODUCT CODE AND THE LOT NUMBER, GRAPHIC ON THE LABEL PRINTED WAS CORRECT. ALSO, THE PRODUCT RETURNED MATCHED WITH THE DESCRIPTION OF THE LABEL.

    Additional Manufacturer Narrative · 1

    ONLY A PICTURE OF THE SAMPLE WAS RECEIVED. UPON VISUAL INSPECTION OF THE PICTURE, A SAMPLE OF PRODUCT CODE W1718TM COULD BE OBSERVED. THE INFORMATION OF THE PRODUCT CODE AND THE LOT NUMBER, GRAPHIC ON THE LABEL PRINTED WAS COMPARED WITH THUNDERBIRD SYSTEM AND THE INFORMATION WAS CORRECT. ACCORDING TO THE PICTURE AND THE INFORMATION OF THE SAMPLE (LOT#), NO ASSEMBLY - INCORRECT COMPONENT ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE PRODUCT WAS STORED NORMALLY IN THE HOSPITAL STOCK IN THE ROOM TEMPERATURE AND WAS NOT RE-STERILIZED. IT WAS NOTICED THAT THE SUTURE WAS WHITE INSTEAD OF BLACK AS WRITTEN ON THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430451 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK KLQ624

    Patients

    Seq Age Sex Outcome Treatment
    1