BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8050517

    MDR report key: 8050517 · Received November 8, 2018

    Report

    Report Number
    8050517
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 24, 2018
    Report Date
    November 1, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MD NOTICED DIFFICULTY USING SUTURE; WHEN SHE LOOKED AT THE NEEDLE, SHE NOTICED THAT THE TIP WAS ALTERED AND BELIEVES THAT A TINY PORTION OF THE NEEDLE TIP MUST HAVE BROKEN OFF (THIS WAS A PREVIOUSLY USED SUTURE (REMNANT)). SHE STATES THAT SHE KNOWS THAT THE NEEDLE TIP WAS NOT RETAINED IN THE PATIENT BECAUSE SHE WOULD HAVE DIFFICULTY REMOVING THE NEEDLE ON PRIOR STITCH. THE SURGEON WAS CONVINCED THAT THE NEEDLE TIP BROKE OUTSIDE OF THE PATIENT. THE NEEDLE WAS REMOVED FROM THE FIELD AND PLACED IN THE SHARP CONTAINER WHERE IT WOULD NOT BE USED AGAIN.

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA