MAUDE Adverse Event Report: CU MEDICAL, INC LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L-70
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device before use, being connected to the infusion bag, it was confirmed that there was breakage on the 2 tube occurred which lead to leakage of circulating water.The event occurred during priming.There was no patient involvement.
Additional Manufacturer Narrative
B3: unknown; day is unknown, month of event is june.No other information has been provided to date.E1: initial reporter establishment name; (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.The device has not been returned to the manufacturer.
Additional Manufacturer Narrative
One used device was received for evaluation.No other damages or anomalies were observed.A leak was observed originating from the crack on the infusate line luer.Functional and visual tests were done and the reported issue can be duplicated.The probable cause is due to environmental stresses on the luer.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): CU MEDICAL, INC; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22841605
• Report Number: 3012307300-2025-09769
• Device Sequence Number: 4848971
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007(17)250830(10)4183072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 08/30/2025
• Device Catalogue Number: L-70
• Device Lot Number: 4183072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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
• Patient Sex: Unknown