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

Catalog Number 2C4041

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a bladder irrigation set leaked.The leak was observed in the part of where the tubing merges and holds fluid.There was no patient involvement.No additional information is available.

• Brand Name: TUR IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7021139
• MDR Text Key: 92212507
• Report Number: 1416980-2017-08966
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: 2C4041
• Device Lot Number: R17E17020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1