MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LTXFR NV TUR Y-SET; CATHETER, IRRIGATION

Catalog Number	065430401
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved the following medical device: ltxfr nv tur y-set.The customer reported that the piercing pins are slightly too small for the ivs, so there was leakage of an unspecified fluid/infusate.There was no harm to the involved patient.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned; however, it has not yet been received.
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
Updated information: the piercing pin has been reported leaking when connected to the 1000ml and 3000ml fluid bags which they order from icu medical.Previously, it was communicated that the leakage issue was occurring at the bag spike end of the tubing.However, the leakage is actually occurring at the opposite end specifically at the catheter adapter that connects to the foley catheter.When the tubing is connected to a scope, there are no issues.However, once the flexible tubing is removed and the tip is attached to a foley catheter, the connection does not remain secure and easily separates.This connection failure has resulted in multiple patients being soaked with urine, both at their facility and in the home setting.There were patient involvement and no patient harm reported.

• Brand Name: LTXFR NV TUR Y-SET
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24241430
• Report Number: 9615050-2026-00040
• Device Sequence Number: 13066599
• Product Code: GBX
• UDI-Device Identifier: 10887787006725
• UDI-Public: 10887787006725
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2026

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: Health Professional
• Device Catalogue Number: 065430401
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 04/22/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/27/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID/INFUSATE, MFR UNK.
• Patient Sex: Unknown