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 01/23/2024

Event Type  malfunction  

Event Description

According to the available information during the procedure the metal rod of the needle became free of its white plastic ring.Exposure of the sharp end of the metal rod to the patient's vessels or organs.

Manufacturer Narrative

The review of the complaint history database, revealed no trends for the lot number 8580871.We received one used sample.After decontamination, we observed that the white connector was unglued from the metallic mandrel.No more issue or damage was observed on the sample.Checking the quality database revealed one non-conformity (nc) in relation with this issue.The gluing step of the white connector on the metallic mandrel has been done before the implementation of the nc's actions.A similar case study was performed based on same item number rja108 and same defect [unglued] over the last four years: 10 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.

• 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: 18731173
• MDR Text Key: 335956541
• Report Number: 9610711-2024-00039
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 03600040257609
• UDI-Public: 3600040257609
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/01/2024

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: 8580871_RJA1081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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