MAUDE Adverse Event Report: ICU MEDICAL INC. TEGO CONNECTOR

Model Number D1000

Device Problems Use of Device Problem (1670); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2017

Event Type  malfunction  

Event Description

Int'l.((b)(6)) complaint received concerning leakage issues with use of unspecified dialysis set-up where d1000 tego connectors were in use.The initial information as translated reports ".Tego cap on a tunnelized double lumen catheter.At the end of the dialysis session, before performing the blood recovery, disconnection of the tubing from the arterial catheter branch, and dysfunctioning of the tego cap which let the air get in the arterial branch.No clinical consequence.".There were no reported adverse patient consequences.The mfr.Has requested additional event / device usage information.As of the date of this report there has been no response.

• 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 dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6793422
• MDR Text Key: 82824919
• Report Number: 2025816-2017-00175
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: 00840619026059
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2017
• 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