BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 45CM 6-0 SB-15

    MDR report key: 8132983 · Received December 5, 2018

    Report

    Report Number
    2210968-2018-77522
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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 CLARIFY DID THE SUTURE BREAK? DID THE SUTURE FRAY? WHEN DID THE EVENT OCCUR, (WHILE IN THE PACKAGE, DURING DISPENSING, DURING USE) CLARIFY THE QUANTITY OF SUTURES THAT EXPERIENCED THIS ISSUE? DID THIS OCCUR DURING ONE PROCEDURE?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INVESTIGATION SUMMARY ==> IT WAS REPORTED PERFORMANCE BREAKAGE SUTURE. AN OPENED BOX WITH TWENTY-NINE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. THE ISSUE SAMPLE WAS NOT RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THIRTEEN SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS, DAMAGED OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE REPRESENTATIVE SAMPLES, NO BREAKAGE SUTURE WAS FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE APPEARED TO BE "FRAGILE" POSSIBLY EASILY TORN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973125 SILK BLK 45CM 6-0 SB-15 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. LL6748

    Patients

    Seq Age Sex Outcome Treatment
    1