MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 46" (117 CM) 50 ML, DILUENT SET FOR CHANNEL 2 W/20 DROP DRIP CHAMBER, SPIROS¿; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH4002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional reporter (b)(6).
Event or Problem Description
An email was received regarding a 46 50 ml diluent set for channel 2, spiros, alleging a leak during patient use.It was stated in the report that there was leakage from the spiros.The event was noted during infusion.Moriamin-sn was involved in the event.There was no bleedback reported.The product is not a biohazard, and the device was not reprocessed/resterilized.There was patient involvement but no patient harm.There was no delay in critical therapy.
Additional Manufacturer Narrative
D7a - single use device: no.
Additional Manufacturer Narrative
Received one (1) used.List #ch4002, 46" (117 cm) 50 ml, diluent set for channel 2 w/20 drop drip chamber, spiros¿; lot #13659713.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample was tested, and a leak was observed at the connection of the syringe and the transfer set.The sample was disconnected and found to have a broken luer in the syringe.The probable cause of the broken syringe is from an unintentional bending force during use.A device history review (dhr) of lot #13659713 and relevant commodities was reviewed, and the following discrepancy was found.Discrepancy: what? one unit, part number x1-4693 rev.01, lot #13753212, was reported to leak.When? september 13, 2023.Where? during the receiving inspection process, aql 0.025 c=0.Quantity impacted: 47,451 pieces.

• Brand Name: 46" (117 CM) 50 ML, DILUENT SET FOR CHANNEL 2 W/20 DROP DRIP CHAMBER, SPIROS¿
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23507064
• Report Number: 9617594-2025-02139
• Device Sequence Number: 15708563
• Product Code: ONB
• UDI-Device Identifier: 00840619054786
• UDI-Public: (01)00840619054786(17)281001(10)13659713
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173477
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2025

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 Catalogue Number: CH4002
• Device Lot Number: 13659713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 12/10/2025
• Initial Report FDA Received Date: 11/09/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MORIAMIN-SN
• Patient Sex: Unknown