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

Catalog Number 2C4041

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a y-type tur/bladder irrigation set leaked "from connection of tube" (not further specified).This issue was identified during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: the device was received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including clear passage and pressure testing were performed which revealed a leak between the tubing inside the drip housing.The reported problem was verified.The cause of the condition was due to manufacturing issue.There are controls in place for risk reduction in order to prevent and detect leaks.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.

• 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; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8883671
• MDR Text Key: 153984418
• Report Number: 1416980-2019-04373
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4041
• Device Lot Number: R18G25028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2018
• 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