MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. RIO¿ DRUG RECONSTITUTION TRANSFER DEVICE; SET, I.V. FLUID TRANSFER

Catalog Number	VB-20
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation - it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding to a rio transfer devices in which it was reported that the device have floating particles and ¿hair like¿ substance on the device when opened from package upon inspection.No patient involvement and no harm were reported.
Additional Manufacturer Narrative
A couple of photos were shared by customer where debris, hair, and contamination are noted on the samples, none of them is observed in the fluid path, no additional damage or anomalies are observed on the photos.Complaint of particulate matter can be confirmed.The probable cause is an error during gowning process in manufacturing.Lot history review was conducted, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: RIO¿ DRUG RECONSTITUTION TRANSFER DEVICE
• Common Device Name: SET, I.V. FLUID TRANSFER
• 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: 23888551
• Report Number: 9617594-2025-02334
• Device Sequence Number: 9605482
• Product Code: LHI
• UDI-Device Identifier: 00887709120594
• UDI-Public: (01)00887709120594(17)300501(10)14419545
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: VB-20
• Device Lot Number: 14419545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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