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 Problems Material Separation (1562); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

According to available information, this device required replacement due to disconnection.When the metal stylet was withdrawn, the connector came off.The metal stylet could not be withdrawn from device.The device and metal stylet was removed and replaced.No other adverse patient effects were reported.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 the available information, the white luer came off on a kolibri product.

Manufacturer Narrative

The review of the complaint history database, revealed one similar incident for the lot number 9054015.Checking the quality database revealed one non-conformity related to this issue.In august we received one used sample.According to the observation, white connector was unglued, no more issue or damage was observed.

• 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: 17470349
• MDR Text Key: 320516969
• Report Number: 9610711-2023-00165
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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: RJA108
• Device Lot Number: 9054015_RJA1081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1