MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 2C4041

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of an unspecified number of yy-type tur/bladder irrigation sets were leaking.It was further reported that during "ureteroscopy procedures the tubing leaks when under pressure (leaks at the amber tubing/cone tip site0".This issue was identified during use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TUR IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9281038
• MDR Text Key: 165396762
• Report Number: 1416980-2019-06129
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 00085412001067
• UDI-Public: (01)00085412001067
• Combination Product (y/n): N
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C4041
• Device Lot Number: R19A07036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1