MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 1O2¿ VALVE (BLUE) W/CHECK VALVE, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	01C-SMV3V
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 1o2¿ valve (blue) w/check valve, rotating luer where the customer reported that a leak occurred during use on a 70 year old male patient.The incident occurred in a medical institution and the patient was being treated for multifunctional organ failure and rehydration treatment when liquid seepage was found at the connection of the wantong valve during fluid rehydration treatment.A new wantong valve was immediately replaced and the liquid was input smoothly.There was patient involvement but no patient harm reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for evaluation.Lot history review pending.Additional contact information beijing jaspar medical supply co., ltd.Qiny qiny1016@163.Com 010-5820 5318 china.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.A lot review was conducted and a similar complaint was confirmed on a sample from the same lot.The reported complaint can be confirmed based on the lot review.The probable cause is related to a molding defect in white button molded component used in the 1o2 smart valve.

• Brand Name: 1O2¿ VALVE (BLUE) W/CHECK VALVE, ROTATING LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20334467
• Report Number: 9617594-2024-01362
• Device Sequence Number: 9728374
• Product Code: FPA
• UDI-Device Identifier: 00887709042391
• UDI-Public: (01)00887709042391(17)281001(10)13797662
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 01C-SMV3V
• Device Lot Number: 13797662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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 Age: 70 YR
• Patient Sex: Male