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 been received.
Event or Problem Description
An event involved a rio transfer device stated that the device has black hairs along blue spike.There was no patient involvement and no reported patient harm / injury.
Additional Manufacturer Narrative
D9 - date returned to mfr: 1/12/2026.Photos were returned showing fibers on the rio and a hair in the packaging.Received one (1) open/unused vb-20 rio drug reconstitution transfer device for inspection.The sample was visually examined.Two (2) small fibers were found on the vb-20.The fibers were outside of the fluid path.The reported complaint can be confirmed.The root cause of this event is being investigated under capa-0010437.Corrective and preventive actions will be defined and implemented based on the outcomes of this investigation.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.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.

• 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: 24050184
• Report Number: 9617594-2026-00022
• Device Sequence Number: 9856266
• Product Code: LHI
• UDI-Device Identifier: 00887709120594
• UDI-Public: (01)00887709120594(17)300801(10)14529909
• 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: 14529909
• 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: 09/01/2025
• 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