BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEK J PERCUTANEOUS NEPHROSTOMY CATHETER

    MDR report key: 17651132 · Received August 30, 2023

    Report

    Report Number
    9610711-2023-00190
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    April 16, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    LJE
    UDI-DI
    03600040256527
    PMA / PMN Number
    K211911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 9080255. 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. A SIMILAR CASE STUDY WAS PERFORMED OVER LAST FOUR YEARS BASED ON SAME ITEM NUMBER RCJ110, SAME ITEM DEFECT BROKEN, SIMILAR CASE WERE FOUND ((B)(4)). ON 16TH AUGUST, WE RECEIVED ONE USED SAMPLE AFTER INVESTIGATION, WE OBSERVED THAT THE CONNECTOR WAS DISCONNECTED FROM THE STYLET. WE SUPPOSED THAT THE ROOT CAUSE IS A GLUING PROBLEM. FOR THIS ISSUE THE NC (B)(4) COVERS THE LOT NUMBER MADE IN MAY 2022. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ 209 : RISK IDENTIFED ARE NUMBER 13274 AND 13274A; HAZARDOUS SITUATION: CATHETER IS NOT CORRECTLY POSITIONED. THIS HAS SHOWN THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BREAK. BEFORE FITTING THE CATHETER OVER THE GUIDEWIRE, WHEN THE DEVICE WAS GETTING READY FOR USE, THE DOCTOR UNSCREWED THE PLASTIC INNER THREAD CONNECTOR AND TRIED TO WITHDRAW THE PLASTIC INNER THREAD WHEN THE WHITE CONNECTOR OF METAL STYLET CAME OFF. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BREAK. BEFORE FITTING THE CATHETER OVER THE GUIDEWIRE, WHEN THE DEVICE WAS GETTING READY FOR USE, THE DOCTOR UNSCREWED THE PLASTIC INNER THREAD CONNECTOR AND TRIED TO WITHDRAW THE PLASTIC INNER THREAD WHEN THE WHITE CONNECTOR OF METAL STYLET CAME OFF. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302607 VORTEK J PERCUTANEOUS NEPHROSTOMY CATHETER NEPHROSTOMY CATHETER LJE COLOPLAST A/S 9080255_RCJ1101002 03600040256527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown