BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT

    MDR report key: 17091420 · Received June 8, 2023

    Report

    Report Number
    9610711-2023-00122
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Report Date
    August 31, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K170362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT NUMBER: 9070782. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    WE HAVE BEEN INFORMED ABOUT A DEFECT PRODUCT: JJ IN CH. 8 IN THE PACKAGING. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SAMPLE ARE AVAILABLE AND THE LOT NUMBER. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS WITH THE SAME LOT NUMBER 9070782 WE FOUND FOUR OTHER COMPLAINTS. CHECKING THE QUALITY DATABASE REVEALED NO ANOMALY IN RELATION WITH THE DESCRIBE DEFECT. ON JULY WE RECEIVED SEALED SAMPLE. AFTER OBSERVATION WE NOTE THAT JJ ITEM NUMBER YCV284 CH8 WERE PACKAGED INSTEAD OF JJ ITEM NUMBER (B)(4) CH7 WERE PACKAGED. PRODUCTION UNIT FOR THIS PRODUCT WAS INFORMED ABOUT THIS DEFECT. AN AWARENESS WAS ALREADY DONE ABOUT THIS TOPIC ON MAY. SIMILAR CASE STUDY WAS DONE BASED ON SAME ITEM NUMBER, SAME DEFECT (PACKAGING/LABELLING ERROR), OVER LAST FOUR YEAR, AND 5 OTHERS COMPLAINTS (SAME ISSUE BUT DUPLICATE FOR EMDR).

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE ITEM NUMBER WAS A 7 CH/FR DEVICE; HOWEVER, THE STENT IN THE PACKAGE WAS 8 CH/FR. THE PUSHER WAS 7 CH/FR, SO THE CONNECTION DID NOT FIT INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275236 VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT STENT, URETERAL FAD COLOPLAST A/S BCFG741002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown