BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFSILK 3-0 BK 5X18 CV-24 D-TACH

    MDR report key: 6285859 · Received January 30, 2017

    Report

    Report Number
    9612501-2017-00178
    Event Type
    Injury
    Date Received
    January 30, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 10, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GAP
    PMA / PMN Number
    K981128
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AFTER 6 PACKETS WERE USED FOR SUTURING OF INTESTINAL MEMBRANE, THE NURSE OPENED THE SEVENTH PACKET AND REMOVED 1 NEEDLE FROM THE PACKET. IT WAS THEN NOTED THAT THERE WERE 5 NEEDLES LEFT IN THE PACKET AT THE TIME. THEY COUNTED THE NUMBER OF THE NEEDLES AND CONFIRMED THERE WAS 1 TOO MANY NEEDLES THERE. THEY CONFIRMED NO NEEDLE WAS LEFT INSIDE THE PATIENT'S ABDOMINAL CAVITY BY A POSTOPERATIVE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70438 SOFSILK 3-0 BK 5X18 CV-24 D-TACH SUTURE, NONABSORBABLE, SILK GAP COVIDIEN GSJ37M D6D0882X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention