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 Codes	Particulates (1451); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 dec 2025 has been used as a placeholder.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 three rio transfer devices, in which it was reported stated that the devices have what appears to be plastic in critical access areas for sterile compounding.No reported patient involvement or harm.
Additional Manufacturer Narrative
A couple of photos were shared by customer, where a small black spot is observed on the white spike in different locations, but not in the fluid path, no additional damage or anomalies are observed on the photos.Six (6) open/unused.List #vb-20, rio¿ drug reconstitution transfer device were returned for evaluation.As received, the 6 open packages were visually inspected, finding hair and fibers all over the samples and outside of the fluid path.In 1 sample an embedded back spot was found, no additional anomalies were confirmed.Small black embedded spot was measured and based on the size this met the product specification.Additionally, the black spot found embedded in the molding plastic piece was not confirmed since, the size was too small therefore this is not a rejectable condition.Complaint of particulate matter can be confirmed based on particulates on the samples.The probable cause is an error during gowning process.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 12/29/2025.Additional information in b5.
Event or Problem Description
Updated information received stating the device had floating particles and ¿hair like¿ substance on the device when opened from package upon inspection.No patient involvement or harm.

• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23887907
• Report Number: 9617594-2025-02331
• Device Sequence Number: 9622776
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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