BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE

    MDR report key: 2971498 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01344
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE VISUAL INSPECTION SHOWS SEVERAL MARKS OF INSTRUMENT WERE FOUND ON THE THREAD. AT ONE POINT THE THREAD WAS CUT IN AND THEN SPLICED. A NON DAMAGED AREA OF THE ACTUAL THREAD WAS TESTED FOR KNOT PULL AND THE DEVICE PERFORMED ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2013-01345. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76155 PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE SUTURE, NON ABSORBABLE GAW ETHICON, INC. NA EJR295

    Patients

    Seq Age Sex Outcome Treatment
    1