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	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.
Event or Problem Description
The event involved a rio transfer devices where it was reported that the device had "black specs" along spike and "black string under white cap".There was no patient involvement.There were 13 incidents with no other identifying information provided.
Additional Manufacturer Narrative
D9 - date returned to mfr: 1/12/2026.Received one (1) used vb-20 rio drug reconstitution transfer device connected to a vial and twelve (12) used vb-20 rio for inspection.Each sample was visually examined.Small fibers were examined on each used set.The fibers were outside of the fluid path.The reported complaint can be confirmed.The root cause of this event is being investigated under a capa.A corrective and preventative action (capa) plan has been implemented to address the identified issue.The outcome of the capa is currently under evaluation and is not yet finalized.The lot history was reviewed, 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: 24037489
• Report Number: 9617594-2026-00017
• Device Sequence Number: 9074485
• Product Code: LHI
• UDI-Device Identifier: 00887709120594
• UDI-Public: (01)00887709120594(17)300501(10)14426623
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 14426623
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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