BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE MARROW BIOPSY / ASPIRATION TRAY W/ BIOPSY & ASPIRATION NEEDLE / STERILE / L

    MDR report key: 22052711 · Received May 20, 2025

    Report

    Report Number
    2433012-2025-00002
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 16, 2025
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES
    Product Code
    PRV
    UDI-DI
    00849233013278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED FOLLOWING RECEIPT OF A COMPLAINT REGARDING A BENT NEEDLE OBSERVED DURING A BONE MARROW BIOPSY. THE REPORTER CONFIRMED THE NEEDLE APPEARED NORMAL DURING INSERTION, WITH RESISTANCE ONLY NOTICED UPON REMOVAL. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE PRODUCT'S INSTRUCTIONS FOR USE, AND NO UNUSUAL PATIENT ANATOMY OR POSITIONING WAS REPORTED. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY, AND THE INCIDENT WAS DESCRIBED AS ISOLATED BY THE FACILITY. ALTHOUGH AN IMAGE OF THE NEEDLE WAS SUBMITTED, THE PHYSICAL SAMPLE WAS NOT RETURNED DESPITE MULTIPLE FOLLOW-UP ATTEMPTS. THE USER CONFIRMED THAT A BONE MARROW SAMPLE WAS SUCCESSFULLY OBTAINED DURING THE PROCEDURE. A COMPREHENSIVE REVIEW OF MANUFACTURING AND QUALITY CONTROL RECORDS, ALONG WITH A RE-INSPECTION OF CURRENT INVENTORY, REVEALED NO DEVIATIONS OR ISSUES. NOTABLY, THE REPORT REFERENCED AN I-STYLE NEEDLE, WHILE THE IMAGE SHOWED A J-STYLE NEEDLE. A PREVIOUS COMPLAINT FROM THE SAME FACILITY INVOLVED A SIMILAR ISSUE WITH A J-STYLE NEEDLE, WHERE IMPROPER TECHNIQUE WAS SUSPECTED. IT WAS ALSO NOTED THAT THE PRODUCT WAS USED BEYOND ITS EXPIRATION DATE. BASED ON IMAGE REVIEW AND CONTEXTUAL INFORMATION, THE OBSERVED BENDING COULD BE CONSISTENT WITH FACTORS SUCH AS REPOSITIONING DURING REMOVAL, ADVANCEMENT WITHOUT THE TROCAR, OR IMPROPER INSERTION TECHNIQUE.

    Description of Event or Problem · 0

    ON 04/29/2025 THE FDA FORWARDED REPORT, MW5169163, WHICH WAS SUBMITTED TO THEM TROUGH FDA'S MEDWATCH PROGRAM. UPON REVIEW, THE SUBMISSION WAS MADE FOR BUSSE ITEM 652, LOT#2220860. THE REPORTED NOTED "WHEN THE PROVIDER WAS REMOVING THE BONE MARROW NEEDLE FROM THE PATIENT'S BODY IT HAD A SLIGHT BEND TO IT." IMMEDIATELY, A COMPLAINT INVESTIGATION WAS OPENED, AND REPORTER NOTED IN THE REPORT WAS CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184408 BONE MARROW BIOPSY / ASPIRATION TRAY W/ BIOPSY & ASPIRATION NEEDLE / STERILE / L PRV BUSSE HOSPITAL DISPOSABLES 2220860 00849233013278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown