BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    MDR report key: 18359775 · Received December 19, 2023

    Report

    Report Number
    9610711-2023-00280
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 4, 2023
    Report Date
    May 24, 2024
    Product Code
    LJE
    PMA / PMN Number
    K211911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER. CHECKING THE QUALITY DATABASE REVEALED ONE NON-CONFORMITY POSSIBLY RELATED TO THIS ISSUE: - NC (B)(4) - COMPLAINTS WHITE LUER IS NOT GLUING CORRECTLY" OPENED IN JULY 2022 AND CLOSED IN DECEMBER 2022. A SIMILAR CASE STUDY WAS PERFORMED OVER LAST FOUR YEARS BASED ON SAME ITEM NUMBER AND SAME DEFECT [BROKE]: NO SIMILAR CASE WAS FOUND. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND CONCLUDED THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Additional Manufacturer Narrative · 0

    THE PRODUCT REFERENCE RJA1101002 LOT NUMBER 7910694 HAS BEEN MANUFACTURED FOR (B)(4)PIECES IN FEBRUARY 2021. THIS PRODUCT WAS MADE WITH THE INTERMEDIATE YJ161090 "J CATHETER WITH MANDRIN" LOT NUMBER 7696384 & 7758643. THIS INTERMEDIATE YJ161090 LOT NUMBER 7758643 HAS BEEN MANUFACTURED IN NOVEMBER 2020 WITH INTERMEDIATE PRODUCT YJ161070 LOT NUMBER 7692595 - 7680641 - 7670540 MADE IN NOVEMBER 2020. THESE INTERMEDIATE WAS MADE WITH COMPONENT YD100470 "MANDR-K MANDRIN CORDE SDE EN J" LOT NUMBER 7650688 MADE IN NOVEMBER 2020. CHECKING THE QUALITY DATABASE REVEALED ONE NON-CONFORMITY ON THIS ISSUE: NC (B)(4) "RJC108/208 - COMPLAINTS WHITE LUER IS NOT GLUING CORRECTLY" OPENED IN JULY 2022 AND CLOSED IN DECEMBER 2022.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE WHITE LUER LOCK CAME OFF FROM METALLIC STYLET WITHOUT DIFFICULTY DURING PROCEDURE. THE CONSEQUENCE IS THE LOOP CANNOT BE FORMED IN THE KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953676 VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE LJE 7910694_RJA1101002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown