BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 3243323 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14236
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 08/08/2013.ADDITIONAL INFORMATION - 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): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SCANNING ELECTRON MICROSCOPE PHOTOS REVEALED THE NEEDLE EXHIBITED AMOUNTS OF INTERGRANULAR AND POSSIBLY SOME TRANSGRANULAR FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE NEEDLE WAS EXAMINED FOR ATTRIBUTE DEFECTS AND THE NEEDLE HAD A BROKEN BARREL. NO SUTURE REMNANT WAS OBSERVED INTO THE BARREL. ADDITIONALLY, THERE ARE NOT MARKS ON THE NEEDLE BY USE OF THE NEEDLE HOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. UPON OPENING THE SUTURE, THE NEEDLE WAS DETACHED FROM THE SUTURE MATERIAL. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344194 MONOCRYL PLUS SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK GA6220

    Patients

    Seq Age Sex Outcome Treatment
    1