BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 3140547 · Received May 31, 2013

    Report

    Report Number
    2210968-2013-06335
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE NEEDLE SHOWS A STRONG BENT UP NEEDLE POINT WITH FRACTURE. DURING VISUAL INSPECTION UNDER A LIGHT-MICROSCOPE AT THE BROKEN NEEDLE, SEVERAL MARKS OF INSTRUMENT MARKS WERE FOUND OVER THE NEEDLE POINT AREAS WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. GRASPING IN THE POINT AREA COULD IMPAIR THE PENETRATION AND CAUSE FRACTURE OF THE NEEDLE. GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. CONCLUSION: REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. ALL 9 RETURNED STERILE NEEDLES SHOW INTACT NEEDLE POINTS. 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 AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. THE NEEDLE TIP BROKE DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241222 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA EA8CWTZ0

    Patients

    Seq Age Sex Outcome Treatment
    1