BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3213297 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12627
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 21, 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

    CONCLUSION: THE NEEDLE WAS BROKEN ABOVE AT THE SWAGE AREA AND THERE WERE SEVERELY MARKS ON THE EDGE OF THE BARREL. THE NEEDLE HAD A CORRECT SWAGE. ALSO, THE NEEDLE WAS BENT. THIS CONDITION WAS LIKELY CAUSED BY USE OF THE NEEDLE HOLDER. THE SAMPLE CONDITION SUGGESTS AN IMPROPER HANDLING OF THE NEEDLE/SUTURE. THIS DEFECT CANNOT BE ATTRIBUTED TO THE MANUFACTURING PROCESS.

    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

    DATE SENT TO THE FDA: 08/07/2013.ADDITIONAL INFORMATION: 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 A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. WHILE SUTURING THE SUBDERMAL SKIN IN THE HIP JOINT, THE NEEDLE BROKE AT THE SWAGE. THE NEEDLE PIECE WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313124 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK GCZ720

    Patients

    Seq Age Sex Outcome Treatment
    1