MAUDE Adverse Event Report: COLOPLAST A/S VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

Catalog Number RJA108

Device Problem Fracture (1260)

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

Event Date 11/04/2023

Event Type  malfunction  

Event Description

According to the available information the white luer lock was came off from the metallic stylet without difficulty during procedure.The consequence was the loop cannot be formed in the kidney.

Manufacturer Narrative

The review of the complaint history database, revealed no trends for the lot number.Checking the quality database revealed one non-conformity registered possibly related with this type of this issue: - (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, same item defect [broken]: eleven similar cases were 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.

• Brand Name: VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER
• Type of Device: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
• 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: 18360312
• MDR Text Key: 330987578
• Report Number: 9610711-2023-00281
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 03600040257609
• UDI-Public: 3600040257609
• 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: 05/24/2024

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: RJA108
• Device Lot Number: 8987105_RJA1081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2023
• 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