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

Model Number 011-46107-16

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

Devices returned: one (1) used 011-46107-16 partial segment; one (1) pkgd.011-46107-16 monitoring kit; lot # 3112146, one (1) pkgd.A-line 1cc syringe, one (1) pkgd.Bd 10ml syringe and one (1) pkgd.A 1ml tuberculin syringe.Engineering analysis: visual analysis of the "as-received" partial segment recorded the stopcock (needleless) valve was depressed/recessed position.There were no abnormalities/damages with the returned same lot sample.Performance testing with the same lot samples and mating/access devices recorded no failures/performance 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 leakage issues with use of 011-46107-16 single line transpac iv monitoring kit w/03 ml squeeze flush, safeset reservoir and 3 needleless valves.The initial information received reports the 011-46107-16 "needleless valve fails to perform as expected.After only a few luer and slip-tip syringe accesses, the valve leaks necessitating an undesirable amount of line changes." there were no reported patient injuries, no changes in baseline status and or adverse consequences.Additional information although requested was not available.

• Brand Name: SINGLE LINE TRANSPAC IV 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: 5710880
• MDR Text Key: 47216386
• Report Number: 2025816-2016-00042
• 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: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 011-46107-16
• Device Catalogue Number: 011-46107-16
• Device Lot Number: 3112146: UNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1