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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.If the device is received a follow up report will be sent.
Event or Problem Description
The event occurred on an unspecified date and involved a rio¿ drug reconstitution transfer device where it was reported that the rio was having no fluid pathway.The picture provided showed it looked like the spike was solid.There was unknown patient involvement and unknown human harm reported.
Event or Problem Description
Additional information provided by the customer on december 21, 2023, stating the event occurred during compounding - while preparing to attach a vial to the device.There was no patient involvement and no human harm reported.
Additional Manufacturer Narrative
A single vb-20 rio drug reconstitution transfer device was returned with an occlusion confirmed in the fluid path typical of a broken core pin.The cavity was noted as 5d.The probable cause of the occlusion is typical of a broken core pin during molding.Device history was reviewed a non-conformance was identified which was potentially related to the product problem.

• 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: 18358751
• Report Number: 9617594-2023-01184
• Device Sequence Number: 20860395
• Product Code: LHI
• UDI-Device Identifier: 00887709120594
• UDI-Public: (01)00887709120594(17)280601(10)13678213
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2024

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: 13678213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 02/05/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/19/2024; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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