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

Catalog Number 2C4005

Device Problems Filling Problem (1233); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a y-type tur irrigation set would not flow.During patient infusion, the "flow was restricted".There was no patient injury or medical intervention.No additional information is available.

Manufacturer Narrative

F10/h6: device code: 2991 corrected to 1233.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed using the naked eye, did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, including pressure testing and clear passage test.And it was noted, that the flow was restricted, due to the tubing and bushing was crushed.The reported condition was verified.The cause of the condition was, due to improper assembly, during manufacturing process.A batch review was conducted, and there were no deviations found related to this reported condition, during the manufacture of this lot.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: 11172685
• MDR Text Key: 232520435
• Report Number: 1416980-2020-08492
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 00085412000978
• UDI-Public: (01)00085412000978
• 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,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4005
• Device Lot Number: R19I07062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DRUG