MAUDE Adverse Event Report: ICU MEDICAL, INC. MARVELOUS VALVE

Model Number 460980416

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Lot review :a two (2) year review of the complaint database for this list/similar problem did record additional reports and investigations.A review of those investigations where devices were returned recorded mixed results, including no defect found; usage; cannot determine and mfg./ design.Visual analysis: 1/7/2016 - received one (1) used 460980416, 2 marvelous valves bonded, lot# unknown.The silicone plug of one marvelous valve is confirmed to be stuck down.Functional testing :functional testing could not be performed as the damage to the valve rendered it unusable.Analysis summary: the customer complaint of a stick down on the sampling port was confirmed.The returned sample was observed to have the marvelous valve depressed, and it was stuck in this condition.Although not always repeatable, previous engineering analysis of these valve components have shown recessed/leakage condition can potentially occur if the valve component is activated with a long luer or a luer with sharp edges at an angled entry.For optimal performance it is recommended to use connector devices that comply with iso 594-1 std.And techniques that employ a rotational motion while connecting and disconnecting the mating device to the valve.To prevent this in other facilities a switch has been made from luer slip to luer lock syringes and vacutainers.Ensure that the central axis of the connector and valve are inline with each other when connecting and disconnecting and not at an angle.

Event Description

Complaint received regarding three(+) 460980416, 2 marvelous valves bonded, lot# unknown.Report states, sampling port reportedly remained in the pressed down position during the blood sampling process.The lav used to withdraw sample was accessed with a luer slip syringe (1cc abg syringe).No serious adverse patient consequences reported.

• Brand Name: MARVELOUS VALVE
• Type of Device: MARVELOUS VALVE
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 5374050
• MDR Text Key: 36263689
• Report Number: 2025816-2016-00001
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 460980416
• Device Catalogue Number: 460980416
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1