BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 16275779 · Received February 1, 2023

    Report

    Report Number
    9610711-2023-00005
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 3, 2023
    Report Date
    March 22, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    LJE
    PMA / PMN Number
    K211911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    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 SAMPLE WAS RECEIVED ON 16 JANUARY 2023. VISUALLY WE SAW THAT THE WHITER LUER IS DISMANTLED OF THE METALLIC MANDREL. THIS ISSUE WAS KNOWN AND A AWARENESS WITH OPERATORS WAS DONE ON (B)(6) 2022 ABOUT THIS TOPIC. FURTHERMORE AN UPDATE OF THE PRODUCTION MONITORING SHEET CONCERNING THE GLUING STEP WAS IMPLANTED. THE CLINICAL ASSESMENT /AS MENTIONED IN OUR IFU, J OR MALECOT PERCUTANEOUS NEPHROSTOMY CATHETERS MUST ONLY BE USED BY TRAINED AND EXPERIENCED PROFESSIONALS. THE EXAMINATION OF INCRIMINATED DEVICES AND THE INVESTIGATION CONCLUDED THAT A ROOT CAUSE FOR THE INCIDENT WAS A DEVICE DEFECT. THE INCIDENT ¿LUER LOCK UNSTUCK¿ FROM THE STYLET TUBE DURING BILATERAL J PERCUTANEOUS NEPHROSTOMY CATHETER PLACEMENT (IN BOTH KIDNEYS) IS KNOWN ISSUE (NC TW779229 "RJC108/208) RELATED TO PRODUCT DEFECT (WHITE LUER IS NOT GLUING CORRECTLY). WE ESTIMATE THAT ¿LUER LOCK UNSTUCK¿ FROM THE STYLET TUBE, WITH RISKS OF KIDNEY PERFORATION, BLEEDING, INFECTION, SIGNIFICANT PROLONGED PROCEDURE, REPRESENTS A CLINICAL RISK RATED SEVERITY PARAMETER LEVEL 4 REFERRING TO OUR CLINICAL RISK MANAGEMENT PROCEDURE (B)(4). THE RMF IS RISK IDENTIFICATION EXTRACT CRIQ209 RISK NO (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXTRA TIME TO REMOVE DUE TO A DETACHED CONNECTOR. THE WHITE LUER-LOCK DETACHED FROM THE MANDREL. THE MANDREL DID NOT SLIDE IN THE DEVICE AND THE SURGEON HAD TO REMOVE IT IN ONE BLOCK. THE ANESTHESIA WAS EXTENDED AN ADDITIONAL HOUR. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034559 UNKNOWN VORTEK J CATHETER WITH STYLET LJE COLOPLAST A/S RCJ1081002 8886615

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention