BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3900511 · Received June 27, 2014

    Report

    Report Number
    2210968-2014-08380
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2014 AND SUTURE WAS USED. THE NEEDLE BROKE AT THE VERY END WHERE THE NEEDLE CONNECTS TO THE SUTURE MATERIAL. THE PROCEDURE WAS FINISHED WHEN THEY FOUND THAT THE NEEDLE WAS MISSING. THE NEEDLE WAS LOCATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377083 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK HBZ404

    Patients

    Seq Age Sex Outcome Treatment
    1