TUR IRRIGATION SET
Received Apr 24, 2026 · Event occurred Feb 26, 2026
Report 1416980-2026-01453 · MDR key 24988233
Device
Generic name
System, Irrigation, Urological
Manufacturer
Baxter Healthcare CorporationModel number
2C4041Catalog number
2C4041
Lot number
NI
Product problems
- Backflow
- Free or Unrestricted Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4 UDI: AS THE LOT # IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. 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.
Description of Event or Problem
IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET CLAMP WAS NOT HOLDING UNDER PRESSURE, RESULTING IN FLUID BACKFLOW INTO A SECOND MEDICINE BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.