BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2091950 · Received May 18, 2011

    Report

    Report Number
    2210968-2011-00647
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ETHICON INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE CONCERNED SAMPLE SHOW A BREAKAGE IN THE ATTACHMENT AREA. DURING VISUAL INSPECTION UNDER A LIGHT-MICROSCOPE SEVERAL HEAVY MARKS OF NEEDLE HOLDER WERE FOUND IN THIS AREA WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. CONCLUSION: THE DEVICE INFORMATION FOR USE CAUTIONS THE USER THAT "TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT." 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 CESAREAN SECTION PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE PIECES COULD NOT BE FOUND DIRECTLY. THE PATIENT UNDERWENT X-RAY TO LOCATE THE NEEDLES PIECES. IT IS BELIEVED THAT ADDITIONAL TISSUE DISSECTION WAS REQUIRED TO REMOVE THE NEEDLE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURES, ABSORBABLE GAM ETHICON INC NA DA8DBKQ0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention