BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATOR, CATHETER, URETERAL

    MDR report key: 15328637 · Received August 31, 2022

    Report

    Report Number
    9610711-2022-00064
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Report Date
    August 31, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZN
    PMA / PMN Number
    K201007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE NAME: IN-KA URETERAL BALLOON DILATATION CATHETER. MANUAL LOT: 8268006. ACCORDING TO THE COMPLAINT DESCRIPTION, THE LOT NUMBER AND THE SAMPLE ARE AVAILABLE. THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 8268006. THE PRODUCT REFERENCE BD41441002 LOT NUMBER 8268006 HAS BEEN MANUFACTURED FOR (B)(4) PIECES IN OCTOBER 2021. THE EXPIRY DATE IS MARCH 2024. THIS PRODUCT IS A KIT COMPOSED OF: YD400490 CPKIT-SDE DILAT URETERA, LOT NUMBER 7931252, EXPIRY DATE IS MARCH 2024. YD400490 CPKIT-SDE DILAT URETERA, LOT NUMBER 8051914, EXPIRY DATE IS JUNE 2024. SW0105 CMPST-SERIN B-D 10CC LUER LOCK, LOT NUMBER 1710160081, EXPIRY DATE IS AUGUST 20222. CHECKING THE QUALITY DATABASE REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED EFFECT "EXPIRE DATE". THE DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, IT WAS NOTED THAT THE EXPIRY DATE OF THE KIT IS LONGER THAN THE EXPIRY DATE OF ONE OF THE COMPONENTS. KIT'S EXPIRY DATE: 25MAR2024; COMPONENT EXPIRY DATE 300912: 31AUG2022. NO PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069557 DILATOR, CATHETER, URETERAL EZN COLOPLAST A/S BD41441002 NOT IN LIST

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other