BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2860852 · Received December 6, 2012

    Report

    Report Number
    2210968-2012-07934
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, 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

    (B)(4): THE ACTUAL SUTURE FRAGMENT WITH ATTACHED NEEDLE WERE RETURNED AND VISUALLY AND FUNCTIONALLY EVALUATED. EVIDENCE OF PINCH MARKS ON THE NEEDLE AND ON THE SUTURE FRAGMENT WERE FOUND. THE FRAGMENT END SHOWED CHARACTERISTIC DEFORMATIONS OF BREAKAGE CAUSED BY TRACTION. THE SUTURE BREAKAGE IS LIKELY RELATED TO EXCESSIVE FORCE APPLIED TO THE PRODUCT OR INADEQUATE USE OF SURGICAL INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2012, AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND BROKE WHEN THE FIRST KNOT WAS MADE. ANOTHER LIKE DEVICE WAS USED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA 350974

    Patients

    Seq Age Sex Outcome Treatment
    1