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

Catalog Number 2C4040

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a irrigation set was leaking.The reporter stated that the leak was due to a use error as the facility was taping the set to an adapter for irrigation.There was no patient involvement.No additional information is available.

• Brand Name: CYSTOSCOPY 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: 6621753
• MDR Text Key: 76974807
• Report Number: 1416980-2017-04858
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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