MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC® IV MONITORING KIT W/SAFESET/NEEDLELESS VALVES

Model Number 46103-68

Device Problems Leak/Splash (1354); Reset Problem (3019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The involved device was not returned for analysis and confirmation.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 594-1std.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.The exact cause of the reported event/product issue are unknown.Device not returned.

Event Description

Complaint received reporting component issues (needleless valve stick-down/leakages) with use of 46103-68 transpac iv mtg kit w/safeset resv.; intraflo flush; needleless valve.The initial information received reports on (b)(6) the 46103-68 kits ".Luer actived stopcock experienced a "stick-down" during the blood sampling process resulting in blood spurting from the port when attempting to flush the line.".The device was removed, replaced and discarded.There were no reported adverse patient consequences.

• Brand Name: TRANSPAC® IV MONITORING KIT W/SAFESET/NEEDLELESS VALVES
• Type of Device: MONITORING KIT
• 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: holly imes ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6586151
• MDR Text Key: 75858807
• Report Number: 2025816-2017-00126
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46103-68
• Device Catalogue Number: 46103-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1