BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI

    MDR report key: 18196256 · Received November 22, 2023

    Report

    Report Number
    3009495876-2023-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 12, 2023
    Report Date
    November 22, 2023
    Manufacturer
    BEILUN PLASTECH INC
    Product Code
    NWT
    UDI-DI
    00812608021529
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON OCTOBER 12TH A LAPAROSCOPIC CHOLANGIOGRAM CATHETER WITH PART NUMBER PMIORCAP20 AND LOT NUMBER 030220401 WAS TAGGED AS DEFECTIVE AFTER THE TIP DISCONNECTED FROM THE CATHETER AS THE SURGEON WAS INSERTING IT IN THE PATIENTS GALLBLADDER FOR DYE INFUSION FOR A CHOLANGIOGRAM. IT WAS NOT REPORTED THAT THE TIP WAS EVER LOOSE INSIDE THE PATIENT. NO HARM TO PATIENT OR COMPLICATIONS WERE REPORTED. NO ADVERSE EVENT WAS REPORTED. THE DEVICE IN QUESTION WAS NOT RETURNED FOR INVESTIGATION. THIS IS THE FIRST PRODUCT PROBLEM WITH PMIORCAP20 LOT NUMBER 030220401. ONLY ONE DEVICE FROM THE LOT OF 200 IS AFFECTED. THERE HAVE BEEN NO SIMILAR REPORTS FOR THIS LOT OR THIS DEVICE AS A WHOLE. PATIENT INFORMATION NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203792 PMI PMI COMBO PACK - CHOLANGIOGRAM CATHER WITH DISPOSABLE PERCUTANEOUS INTRODUCER NWT BEILUN PLASTECH INC PMIORCAP20 030220401 00812608021529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown