TUR IRRIGATION SET 2C4041

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for TUR IRRIGATION SET 2C4041 manufactured by Baxter Healthcare - Cartago.

Event Text Entries

[134366961] (b)(4). The device was received for evaluation. The returned unit was labeled for single use. Visual inspection revealed that both clamps were missing from the set. The reported condition was verified. The cause of the condition was determined to be an assembly issue during manufacturing. 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.
Patient Sequence No: 1, Text Type: N, H10

[134366962] This report summarizes 1 malfunction events. It was reported that both clamps were missing from a y-type tur/bladder irrigation set. This was identified during priming. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-00322
• MDR Report Key: 8283050
• Date Received: 2019-01-28
• Date of Report: 2019-01-28
• Date Mfgr Received: 2018-12-31
• Date Added to Maude: 2019-01-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: BAXTER HEALTHCARE - CARTAGO
• Manufacturer Street: SEE H10
• Manufacturer City: CARTAGO 30106
• Manufacturer Country: CS
• Manufacturer Postal Code: 30106
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TUR IRRIGATION SET
• Generic Name: SYSTEM, IRRIGATION, UROLOGICAL
• Product Code: LJH
• Date Received: 2019-01-28
• Model Number: NA
• Catalog Number: 2C4041
• Lot Number: R17K29024
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE - CARTAGO
• Manufacturer Address: CARTAGO

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-28