BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2063473 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00443
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ETHICON
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE NEEDLES WERE INSPECTED AND TESTED FOR STRENGTH AND DUCTILITY. THERE WERE NO SIGNS OF MANUFACTURING OR MATERIAL DEFECTS FOUND. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION. 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. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN THE SURGEON WAS PULLING THE SUTURE THROUGH THE FASCIA WITH THE NEEDLE DRIVER. THE NEEDLE FRAGMENT WAS LOCATED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON NA CM2985

    Patients

    Seq Age Sex Outcome Treatment
    1