BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2120589 · Received June 10, 2011

    Report

    Report Number
    2210968-2011-00756
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(6), 2011. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL NEEDLE REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILE FAILURE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. A VISUAL INSPECTION WAS ALSO PERFORMED ON ONE ADDITIONAL LOOSE NEEDLES RETURNED FOR EVALUATION. THERE WERE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. THERE WERE SCUFF MARKS AND INDENTS ON THE NEEDLE THAT APPEAR TO HAVE COME FROM HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6), 2011 AND SUTURE WAS USED. DURING SUTURING OF THE CERVIX, THE NEEDLE TIP WAS MISSING. THE PATIENT WAS THEN EXAMINED UNDER X- RAY TO FIND THE MISSING NEEDLE TIP BUT NOTHING WAS FOUND. THERE WERE 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, INC. NA CC2222

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR