BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 21102439 · Received January 8, 2025

    Report

    Report Number
    1018233-2024-08655
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 20, 2024
    Report Date
    February 7, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741119194
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED AS MANUFACTURING RELATED (CAPA 11207399). THE ROOT CAUSE IDENTIFIED FOR CAPA 11207399 IS: THE LABEL PROCESS DESCRIBED IN THE PROCEDURE WAS NOT FOLLOWED UP BY LABEL PRINTING TECHNICIAN, WHERE ESTABLISHED THAT BEFORE THE PRINTER IS RE-LOADED WITH A NEW MATERIAL LOT, THE LABEL PRINTING TECHNICIAN MUST TAKE THE FIRST LABEL OF THE AT LOT AND MARK WITH RED INK THE PRE-PRINTED MATERIAL PART NUMBER TO CONFIRM THAT IT IS ACCORDING TO THE PART NUMBER LISTED IN OPERATION 10 OF THE WORK ORDER. THIS LABEL SHOULD BE SIGNED, DATED, AND MUST BE INCLUDED IN THE DHR AS SAMPLE; A COMMENT DOCUMENTING THIS MATERIAL LOAD SHOULD BE ADDED IN THE FIRST ARTICLE INSPECTION FORM. A LABELING REVIEW AND DHR REVIEW ARE NOT REQUIRED AS CAPA 11207399 IS APPLICABLE FOR THIS PRODUCT LOT NUMBER. CORRECTION: D, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NOVAPLUSCHANNELDRAIN CAME PACKAGED WITH 15F DRAINS RATHER THAN 19F. PER FOLLOW UP VIA PHONE ON 03JAN2025.THE PRODUCT WAS PACKAGED AS V072231 BUT THE PRODUCT INSIDE WAS V072229. IT WAS USED ON THE PATIENT AND ONCE THEY REALIZED IT WAS THE INCORRECT SIZE, IT WAS REMOVED IMMEDIATELY. NO PATIENT HARM WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NOVAPLUS CHANNEL DRAIN CAME PACKAGED WITH 15F DRAINS RATHER THAN 19F. PER FOLLOW UP VIA PHONE ON 03JAN2025. THE PRODUCT WAS PACKAGED AS V072231 BUT THE PRODUCT INSIDE WAS V072229. IT WAS USED ON THE PATIENT AND ONCE THEY REALIZED IT WAS THE INCORRECT SIZE, IT WAS REMOVED IMMEDIATELY. NO PATIENT HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347781 CHANNEL DRAIN CHANNEL DRAIN GBX C.R. BARD, INC. (COVINGTON) -1018233 NGJV0169 00801741119194

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other