MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO

Model Number D1000

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of lot# 3293931 showed that (b)(4) units were manufactured, tested, inspected and released citing no exception documents.

Event Description

Complaint received regarding one tego, d1000, lot# 3293931 (mfd.07/2016).Report states: a new cap was inserted at 0730.At 2100 dressing full of blood, it seems this leak is due to the cap.Change of cap.Infection risk, the catheter was handled several times.No adverse patient consequences reported.

Manufacturer Narrative

Lot review: a review of lot# 3293931 showed that (b)(4) units were manufactured, tested, inspected and released citing no exception documents.Receipt analysis: 1/10/2017 - received one used tego, d1000, reported lot# 3293931.No mating devices were returned.Blood was under the silicone.Functional testing: the d1000 tego was pressure tested and failed.The d1000 tego was disassembled and there was damage to the one piece seal at the main seal interface.Final analysis summary: the complaint of d1000 tego blood leakage was confirmed with the returned connector.The leakage was the result of damage to the one piece seal at the main seal interface with the body.Icu medical is currently reviewing and implementing continuous improvements to the process th improve the issue.

Event Description

Complaint received regarding one tego, d1000, lot# 3293931 (mfd.07/16).Report states: a new cap was inserted at 0730.At 2100 dressing full of blood, it seems this leak is due to the cap.Change of cap.Infection risk, the catheter was handled several times.No adverse patient consequences reported.

• Brand Name: TEGO
• Type of Device: TEGO
• 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: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 6215531
• MDR Text Key: 63653133
• Report Number: 2025816-2016-00305
• 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: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2021
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: 3293931
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1