BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 20694343 · Received November 15, 2024

    Report

    Report Number
    1018233-2024-07250
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 23, 2024
    Report Date
    February 6, 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
    LA, 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. FIVE PHOTOS WERE RECEIVED FOR EVALUATION. THE FIRST ONE SHOWS A PILE OF 7 BOXES. THE SECOND PHOTO SHOWS THE LABEL ON THE BOX EVIDENCING CAT NO: V072229 15FRROUND HUBBLESS AND LOT: NGJV0169. THE THIRD PHOTO SHOWS BOTH, THE LABEL ON THE BOX AND THE LABEL ON THE PRODUCT PACKAGING, EVIDENCING THAT EVEN THOUGH THE LOT NUMBER IS THE SAME, THE PRODUCT NUMBER IS DIFFERENT SINCE THE LABEL IN THE PACKAGING SHOWS CAT NO: V072231 19FR ROUND HUBLESS. THE FOURTH PHOTO ZOOMS INTO THE PRODUCT LABEL (19FR). THE LAST PHOTO SHOWS THE PRODUCT INSIDE THE BOX, EVIDENCING AGAIN TO BE LABEL AS A 19FR. THE REPORTED EVENT IS CONFIRMED. 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. DHR REVIEW IS NOT REQUIRED AS CAPA: 11207399 IS APPLICABLE FOR THIS PRODUCT LOT NUMBER. LABELING REVIEW IS NOT REQUIRED AS CAPA: 11207399 IS APPLICABLE FOR THIS PRODUCT LOT NUMBER. 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 CUSTOMER HAD TWO SEPARATE POS- PO:4517838642 & PO 4517885835 WHERE THEY HAD RECEIVED THE WRONG PRODUCT. THE BOX WAS MARKED CHANNEL DRAIN 15FR ROUND HUBLESS FULL FLUTED SILICONE WITH 4.7MM TROCAR, BUT THE BOXES ACTUALLY CONTAINED 19FR DRAINS, AND THEY NOW HAD 7 PLUS CASES OF 19FR DRAINS AND NO 15FR DRAINS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD TWO SEPARATE POS- PO: (B)(4) WHERE THEY HAD RECEIVED THE WRONG PRODUCT. THE BOX WAS MARKED CHANNEL DRAIN 15FR ROUND HUBLESS FULL FLUTED SILICONE WITH 4.7MM TROCAR, BUT THE BOXES ACTUALLY CONTAINED 19FR DRAINS, AND THEY NOW HAD 7 PLUS CASES OF 19FR DRAINS AND NO 15FR DRAINS. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 16DEC2024, STATED THAT THESE ARE ALL MISMATCHED. THEY NEVER MADE IT TO THE PATIENT BECAUSE IT WAS CAUGHT BEFORE THE STOCK WAS REFILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334460 CHANNEL DRAIN CHANNEL DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGJV0169 00801741119194

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other