BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 6-0 D/A C-1 EP

    MDR report key: 8663045 · Received June 3, 2019

    Report

    Report Number
    2210968-2019-82263
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031218949
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS REPORTED PERFORMANCE BREAKAGE SUTURE. SIXTEEN UNOPENED SAMPLES WERE RETURNED FOR EVALUATION. THE ISSUE SAMPLE WAS NOT RECEIVED FOR ANALYSIS. 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 PERFORMANCE - BREAKAGE SUTURE WAS FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS. REPRESENTATIVE SAMPLES RETURNED TO SUPPORT INVESTIGATION OF 6 DEVICE ISSUES CAPTURED IN REPORTS 2210968-2019-82262, 2210968-2019-82263, 2210968-2019-82264, 2210968-2019-82265, 2210968-2019-82266, AND 2210968-2019-82267. ANALYSIS RESULTS HAVE BEEN INCLUDED IN FOLLOW-UP REPORTS FOR EACH.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BENTALL (AORTIC VALVE REPLACEMENT) PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THE PROCEDURE WAS DELAYED LESS THAN 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456363 PRLNE BLU 30IN 6-0 D/A C-1 EP SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. MLQ503 10705031218949

    Patients

    Seq Age Sex Outcome Treatment
    1