MAUDE Adverse Event Report: ICU MEDICAL INC 1O2 MANIFOLD; 1O2 VALVE (BLUE) W/CHECK VALVE

Model Number	01-C-SMV3V2
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received six used 01csmv3v2 1o2 valve (blue) w/check valve, rotating luer.Lot review did not show any abnormalities during the manufacturing process.Investigation: visual showed each of the six returned products were received with only one 1o2 sub assembly and each had a check valve.Attached to 3 of the returned 1o2 assemblies were an unknown catheter.Functional testing of the six 1o2 subassemblies with a bonded check valves were retrograde leak tested at 5psi.Sample #3 did exhibit leaking.All other samples exhibited no leaking.There was no check valve leakage observed during testing.Based on these investigation results a continuous improvement team was initiated to further evaluate and determine product performance enhancements to address these type of intermittent component (flow/leakage) issues.
Event or Problem Description
Leakage, may be from the check valve.Blood back flow observed through straight path and side port.There were no adverse patient consequences reported.

• Brand Name: 1O2 MANIFOLD
• Common Device Name: 1O2 VALVE (BLUE) W/CHECK VALVE
• Manufacturer (Section D): ICU MEDICAL INC; 600 n. field dr; lake forest IL 60045
• Manufacturer (Section G): 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 ; 4455 atherton dr.; salt lake city, UT 84123
• MDR Report Key: 19554705
• Report Number: 2025816-2014-00158
• Device Sequence Number: 6711127
• Product Code: FPA
• UDI-Device Identifier: 00887709042421
• UDI-Public: (01)00887709042421(17)180301(10)2470436
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2013

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 Expiration Date: 03/01/2018
• Device Model Number: 01-C-SMV3V2
• Device Catalogue Number: 01-C-SMV3V2
• Device Lot Number: 2470436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2014
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2012
• 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