BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL SUTURE

    MDR report key: 1940251 · Received December 9, 2010

    Report

    Report Number
    2210968-2010-01681
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: ONE ACTUAL BROKEN NEEDLE WAS RETURNED FOR EVAL. THE NEEDLE WAS RECEIVED IN A CONDITION THAT WAS INADEQUATE FOR EVAL. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. RESULT: REP SAMPLE OF THE PRODUCT WAS TESTED FOR NEEDLE STIFFNESS AND DUCTILITY AND THE RESULTS OBTAINED WERE IN CONFORMANCE WITH THE REQUIREMENTS. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPEC. IN ADDITION, A REVIEW OF THE BATCH MFG 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 A SURGICAL PROCEDURE ON (B)(6) 2010. THE NEEDLE POINT BROKE DURING SUTURING. THE SURGEON REMOVED THE NEEDLE FRAGMENT AND COMPLETED THE PROCEDURE WITH A SECOND SUTURE WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA T8002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK