MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO CONNECTOR

Model Number D1000

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Findings: as no devices are available to be returned for analysis and confirmation, the exact cause(s) of this incident/product issue remain unknown.This report and the associated information have been entered in our database for analysis and trending.The data is further communicated to the concerned icu medical management teams and affected disciplines.Device not returned.

Event Description

Int'l.(b)(6) mdr complaint received concerning air in line with use of dialysis set -up with d1000 tego connectors.The initial information received reported "nurse has noticed air inlet issues in the venous external adaptor of the during the disconnection of the bloodline.The cap was well screwed".The involved tego connectors were removed, replaced and discarded.There were no reported tego component damages, defects and or visual abnormalities.There were no reported serious patient injuries and or adverse consequences.

• Brand Name: TEGO CONNECTOR
• Type of Device: TEGO CONNECTOR
• 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: 5535010
• MDR Text Key: 41534822
• Report Number: 2025816-2016-00015
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1