MAUDE Adverse Event Report: COLOPLAST A/S VORTEK J PERCUTANEOUS NEPHROSTOMY CATHETER

Catalog Number RCJ108

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

According to the available information the white connector of the metal stylet came off.

Manufacturer Narrative

The review of the complaint history database, revealed no trends for the lot number.A similar case study was done based on same item number, same defect over last four year: 18 cases were found.On october we received one used sample.According to the visual examination we can define that the white luer was unglued, no other defect was observed.Based on the sample received, the check of the quality database revealed one non-conformity potentially related to this issue: nc (b)(4) "rjc108/208 - complaints white luer is not gluing correctly" opened in july 2022 and closed in december 2022.

Event Description

According to the available information the white connector of the metal stylet came off.

• Brand Name: VORTEK J PERCUTANEOUS NEPHROSTOMY CATHETER
• Type of Device: NEPHROSTOMY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18041075
• MDR Text Key: 326987341
• Report Number: 9610711-2023-00235
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 03600040256381
• UDI-Public: 3600040256381
• Combination Product (y/n): N
• PMA/PMN Number: K211911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RCJ108
• Device Lot Number: 8974920_RCJ1081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1