BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE NEEDLE

    MDR report key: 2814701 · Received October 24, 2012

    Report

    Report Number
    MW5027399
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC
    Product Code
    GAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) WAS ADMITTED ON (B)(6) 2012, FOR ELECTIVE REPEAT C/SECTION. WHEN OB MD WAS SUTURING THE FASCIA LAYER SHE ENCOUNTERED DIFFICULTY IN PIERCING THE FASCIA AFTER SEVERAL SUTURES WERE PLACED. SHE NOTICED THAT THE TIP OF THE SUTURE NEEDLE WAS BLUNTED. UPON INSPECTION OF THE FASCIA SHE RETRIEVED THE TIP OF THE SUTURE NEEDLE (0.1 CM) AND REMOVED BOTH THE TIP AND THE SUTURE NEEDLE FROM THE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE NEEDLE SUTURE NEEDLE GAK MEDICAL ACTION INDUSTRIES INC 844207

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR