BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMI

    MDR report key: 22666723 · Received July 30, 2025

    Report

    Report Number
    3009495876-2025-00001
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BEILUN PLASTECH INC
    Product Code
    GBZ
    UDI-DI
    00812608021017
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    DURING A LAP CHOLE, [THE SURGEON] INSERTED A CHOLANGIOGRAM CATHETER (PMIORCB) THROUGH A SMALL INCISION IN THE ABDOMEN. [THE SURGEON] IS A GENERAL SURGEON WITH MULTIPLE YEARS OF EXPERIENCE WITH THE PROCEDURE AND WITH PMIORCB. DURING INSERTION OF THE CATHETER, THE TIP/BEND OF THE PRODUCT BROKE OFF. THIS PORTION OF THE CATHETER REMAINED IN THE PATIENT'S SUBCUTANEOUS TISSUE IN THE RIGHT UPPER QUADRANT OF THE ABDOMEN. THE BROKEN PORTION WAS LOCATED USING X-RAY IMAGING AND REMOVED. [THE SURGEON] WAS ABLE TO ENLARGE THE INCISION AND COMPLETELY REMOVE THE CATHETER TIP THAT HAD BROKEN OFF. THE PATIENT'S CLINICAL OUTCOME WAS REPORTEDLY "GOOD." THE SURGERY TIME WAS EXTENDED, BUT THE PATIENT EXPERIENCED NO COMPLICATIONS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50057 PMI PMI OPERATIVE CHOLANGIOGRAPHY CATHETER FOR TRADITIONAL OPEN PROCEDURE GBZ BEILUN PLASTECH INC PMIORCB 010230801 00812608021017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention