BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMAN SOLID DIAMOND NEEDLE

    MDR report key: 24630079 · Received March 18, 2026

    Report

    Report Number
    3012495575-2026-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 3, 2026
    Manufacturer
    SURGENTEC, LLC
    Product Code
    KNW
    UDI-DI
    00810131880941
    PMA / PMN Number
    K240664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REP STATED THAT THE DOCTOR IMPACTED THE B-MAN INTO THE CORTICAL BONE OF THE ILIAC CREST TO PIERCE THE CORTEX. HE CONTINUED WITH THE ASPIRATION PROCEDURE AND WHEN HE REMOVED THE NEEDLE, HE NOTICED THAT THE TIP WAS NOT ATTACHED TO THE B-MAN CANNULA. THEY TOOK AN X-RAY AND DETERMINED IT REMAINED IN THE ILIUM. THE REP EXPRESSED THAT THE DOCTOR DID NOT STRIKE THE INSTRUMENT EXCESSIVELY AND DID NOT USE EXCESSIVE FORCE WHILE WORKING WITH THE INSTRUMENT. REP ALSO STATED THAT THIS DID NOT CAUSE THE PATIENT TO STAY UNDER ANESTHESIA LONGER THAN ORIGINALLY ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685857 BMAN SOLID DIAMOND NEEDLE INSTRUMENT, BIOPSY KNW SURGENTEC, LLC 26SUR0027 00810131880941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other