BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3243369 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14238
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 9, 2013
    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
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: A NEEDLE THAT BROKE IN THE BODY WAS SUBMITTED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. THE NEEDLE EXHIBITED AMOUNTS OF INTERGRANULAR AND POSSIBLY SOME TRANSGRANULAR FAILURE. THESE FAILURE MODES ARE NOT COMMON FOR A SH-1 NEEDLE, WHICH TYPICALLY FAILS PRIMARILY IN A DUCTILE MANNER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED FOR KNOTTED SUTURING OF THE GASTROINTESTINAL TRACT. WHEN THE NEEDLE PASSED THROUGH THE TISSUE, IT BROKE. IT WAS REPORTED THAT THE NEEDLE HOLDER AND THE NEEDLE DID NOT WORK WELL TOGETHER, AND PERHAPS THAT IS THE REASON FOR THE NEEDLE BREAKAGE. THE NEEDLE PIECE WAS RETRIEVED AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342874 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1