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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 1o2¿ valve (blue) w/check valve, rotating luer where the reporter stated there was leakage from the white button.The customer reported that occurred during infusion between (b)(6) 2024 and was used for 24 hours.The devices were changed out/replaced with no further problems encountered.There were 6 problematic devices.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no adverse operator consequences and no medical/surgical intervention required.
Additional Manufacturer Narrative
Three used 01c-smv3v 1o2 valve w/ check valve were received for inspection.No defects or anomalies noted.Each valve was connected to a 36" head height fluid reservoir from the side port, primed and left for 24 hours.There was leakage from the white button on one (1) of the received used 01c-smv3v.The reported complaint can be confirmed on one (1) of the returned samples.The probable cause is related to a molding defect in the white button molded component used in the 1o2 smart valve.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
Additional information: (b)(6).

• 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: 20013512
• Report Number: 9617594-2024-01152
• Device Sequence Number: 4374846
• Product Code: FPA
• UDI-Device Identifier: 00887709042391
• UDI-Public: (01)00887709042391(17)280901(10)13749431
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 13749431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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