BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2364445 · Received December 9, 2011

    Report

    Report Number
    2210968-2011-02089
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 16, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. CONCLUSION: THE POINT END OF THE NEEDLE WAS SUBMITTED FOR THIS EVALUATION. A MICROSCOPIC INSPECTION REVEALED SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE POINT 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 POINT END. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    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. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH DJZ608 MFG DATE: 08/16/2011, EXP DATE: 07/31/2016. BATCH DJZ704 MFG DATE: 08/16/2011, EXP DATE: 07/31/2016. BATCH DJZ790 MFG DATE: 08/16/2011, EXP DATE: 07/31/2016. BATCH DJZ791 MFG DATE: 08/16/2011, EXP DATE: 07/31/2016. BATCH DJZ897 MFG DATE: 08/19/2011, EXP DATE: 07/31/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT MYOMECTOMY PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE. THE FRAGMENT WAS REMOVED FROM THE PATIENT'S UTERUS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1