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

Catalog Number RCJ110

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• 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: 17651132
• MDR Text Key: 322291661
• Report Number: 9610711-2023-00190
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 03600040256527
• UDI-Public: 3600040256527
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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 Catalogue Number: RCJ110
• Device Lot Number: 9080255_RCJ1101002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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