BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE

    MDR report key: 3828934 · Received May 23, 2014

    Report

    Report Number
    2210968-2014-06545
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 7, 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). CONCLUSION: 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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL PRODUCT WAS RETURNED FOR EVALUATION. UPON VISUAL EXAMINATION, NO SWAGING ANOMALIES WERE FOUND. TECHNIQUE AND OR FORCE USED TO SEPARATE THE NEEDLE FROM THE SUTURE CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED ON THE PATIENT¿S BLOOD VESSEL. DURING THE PROCEDURE, THE NEEDLE PULLED OFF OF THE SUTURE AND FELL INTO THE PATIENT¿S BODY, BUT IT WAS RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308538 PRONOVA* POLY (HEXAFLUOROPROPYLENE - VDF) SUTURE SUTURE, NON ABSORBABLE, SYNTHETIC GAW ETHICON INC. UNK GMB880

    Patients

    Seq Age Sex Outcome Treatment
    1