BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1872188 · Received October 12, 2010

    Report

    Report Number
    2210968-2010-01288
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE ACTUAL NEEDLE WAS BROKEN IN THE REAR THIRD DUE TO FAULTY HANDLING. VARIOUS INSTRUMENT MARKS WERE FOUND AT THE BREAKAGE AND ALSO AT THE TIP AREA. CONCLUSION: THE DEVICE INFORMATION FOR USE CAUTIONS THE USER THAT "TO AVOID DAMAGING THE NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE THIRD TO ONE-HALF THE DISTANCE FROM THE SWAGED END TO THE POINT. CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM HANDLING. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS". RESULT: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE NEEDLES WERE INSPECTED AND TESTED FOR STRENGTH AND DUCTILITY AND THERE WERE NO SIGNS OF MANUFACTURING OR MATERIAL DEFECTS FOUND. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE NEEDLE BROKE. ALL THE NEEDLE PIECES WERE FOUND AND TAKEN OUT OF THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CC8HLKM0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK