MAUDE Adverse Event Report: ICU MEDICAL, INC. MONITORING KIT W/ NEEDLELESS VALVE; MONITORING KIT W/ NEEDLELESS VALVEV

Model Number 011-46105-57

Device Problems Leak/Splash (1354); Failure to Reset (1532)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

Two used 011-46105-57 mtg.Kits were returned for analysis and investigation.Engineering - visual analysis of the two "as received" used 011-46105-57 mtg kit confirmed the needleless valve component was recessed/septum was damaged on one of the samples.The report noted the second complaint sample contained residual blood in the tubing lines but no obvious abnormalities with the mtg components.Functional pressure leak testing recorded mixed results.The 011-46105-57 complaint unit with the damaged valve septum recorded leakage.The second returned 011-46105-57 complaint unit recorded no leakages and or functional issues.The engineering report documents 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 as well as ensuring 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

Int'l.(b)(6) complaint received reporting component reset issues/leakages with use of 011-46105-57 mtg.Kit with needleless valve and abg luer slip syringes.The information received reports a total of three events that were described as follows "another 2 split valves in the last two days.One of the patient has only been in picu (todays split) and was changed 2 days ago by a picu nurse.(third occurrence).There has been another case.Leaking from the las." there were no reported patient injuries, no changes in baseline status and or adverse consequences.Additional information although requested was not available.

• Brand Name: MONITORING KIT W/ NEEDLELESS VALVE
• Type of Device: MONITORING KIT W/ NEEDLELESS VALVEV
• 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: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5571051
• MDR Text Key: 42504345
• Report Number: 2025816-2016-00023
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 011-46105-57
• Device Catalogue Number: 011-46105-57
• Device Lot Number: 3075214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1