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

Catalog Number 2C4041

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tube of a y-type tur/bladder irrigation set detached.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information/correction was made to previously submitted h10.G1: device manufacturer address will be added: g1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial h10: the device was received for evaluation.A visual inspection was performed, and it was noted, the tubing was separated from the y ¿ vyl component in the upstream part.Additionally, it was observed, that the solvent was not uniformly applied in the circumference of the tubing.Dimensional testing was performed at the tubing.And it was according to specifications.The reported condition was verified.The cause of the condition was, due to lack of solvent applied, during the assembly process.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: 11109354
• MDR Text Key: 224860503
• Report Number: 1416980-2020-08255
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): Y
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1