BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 1667799 · Received April 23, 2010

    Report

    Report Number
    2210968-2010-00418
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 25, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 PT UNDERWENT CARDIOVASCULAR SURGERY ON (B)(6) 2010 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE ON EXIT OF THE STERNUM AND APPEARED TO HAVE FLIPPED ONTO THE FLOOR AWAY FROM THE STERILE FIELD. AN X-RAY WAS TAKEN ON THE OPERATING ROOM TABLE, AND THE NEEDLE WAS NOT RETAINED. A SECOND LIKE DEVICE WAS USED WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAQ ETHICON, INC. NA BME092

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK