MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 8.0 ML, QUINFUSE ADD-ON SET W/4 SPIROS¿, BAG SPIKE, 5 CLAMPS (B; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3225
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
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
Event occurred regarding a spinning spiros® closed male luer, red cap where they reported they found the product in the package is ch3226 instead of ch3225.Device was not use for chemo.Only one (1) device was reported for this complaint.There was no patient involvement, no patient harm and there was no delay in critical therapy.
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary a photo was provided showing the product in the packaging.Only three (3) spiros were observer rather than the four (4) that would be present on a ch3225.It is unable to be determined from the photo why the set configuration did not match the list number.The reported complaint can be confirmed.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history record was reviewed, and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 14" (36 CM) APPX 8.0 ML, QUINFUSE ADD-ON SET W/4 SPIROS¿, BAG SPIKE, 5 CLAMPS (B
• 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: 22789617
• Report Number: 9617594-2025-01665
• Device Sequence Number: 20869239
• Product Code: ONB
• UDI-Device Identifier: 00840619025663
• UDI-Public: (01)00840619025663(17)290601(10)14045180
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: CH3225
• Device Lot Number: 14045180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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