BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE

    MDR report key: 3731223 · Received April 7, 2014

    Report

    Report Number
    2210968-2014-04370
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 16, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION FOUND THAT THE SUTURE PIECES HAD CUT ENDS. NO BREAKAGES WERE OBSERVED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE ENTIRE LENGTH OF SUTURE WAS NOT RETURNED, SO A COMPLETE EXAMINATION WAS NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RASTELLI OPERATION ON (B)(6) 2014 AND SUTURE WAS USED. WHEN KNOTTING THE SUTURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209442 PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE SUTURE, NON ABSORBABLE, SYNTHETIC GAW ETHICON INC. GLP418

    Patients

    Seq Age Sex Outcome Treatment
    1