MAUDE Adverse Event Report: ICU MEDICAL, INC. 5 GANG 4-WAY NANOCLAVE® STOPCOCK

Model Number AC205

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Device return: one (1) used ac205; seven (7) unused/pkgd.Ac205 lot# 3372476 findings: engineering analysis of the as-received ac205 device visually confirmed the reported component separation (nanoclave connector - stopcock).The root cause of the separation could not be determined.The remaining seven returned ac205 devices were tested and analyzed per the applicable product specifications.The results recorded no performance and or out of spec conditions.

Event Description

Complaint received reporting component separation/leakage issues with use of ac205 5 gang 4-way nanoclave® stopcock.The initial information received reports there have been multiple occurrences where the ac205 device ".Integrated microclave just pops right off.".There were no reported adverse patient consequences.Additional event/device information although requested was unavailable.

• Brand Name: 5 GANG 4-WAY NANOCLAVE® STOPCOCK
• Type of Device: 5 GANG 4-WAY NANOCLAVE® STOPCOCK
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton drive; salt lake city 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 84123 ; 8012641702
• MDR Report Key: 6946544
• MDR Text Key: 90208343
• Report Number: 2025816-2017-00216
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080077
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: AC205
• Device Catalogue Number: AC205
• Device Lot Number: 3372476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1