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

Catalog Number	2C4005
Medical Device Problem Codes	Filling Problem (1233); No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional Manufacturer Narrative
F10/h6: device code: 2991 corrected to 1233.Should additional relevant information become available, a supplemental report will be submitted.
Additional 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
• Common Device Name: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11172685
• Report Number: 1416980-2020-08492
• Device Sequence Number: 16782050
• Product Code: LJH
• UDI-Device Identifier: 00085412000978
• UDI-Public: (01)00085412000978
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K960787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/17/2021; 02/17/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/18/2021; 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DRUG