MAUDE Adverse Event Report: ICU MEDICAL, INC. 7" SMALLBORE EXT. SET W/NEUTRON7" SMALLBORE EXT. SET W/NEUTRON

Model Number NC107

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

Lot# review: a review of lot# 3238790 showed that 1,150 units were manufactured, tested, inspected and released in (b)(4) 2016, citing no anomalies.Discarded at facility.

Event Description

Complaint received regarding one nc107, 7" smallbore ext.Set w/neutron, clamp and rotating luer; lot# 3238790 (mfd.(b)(6) 2016).The report states, a small bore quadfuse had been attached to the neutron valve extension set.When the quadfuse extension was removed, it was noted that the plastic end of the neutron valve was missing.It delayed an emergency procedure as the neutron extension set had to be replaced prior to giving the emergency medication.There were no adverse patient consequences reported but there was a delay in in critical therapy.

• Brand Name: 7" SMALLBORE EXT. SET W/NEUTRON7" SMALLBORE EXT. SET W/NEUTRON
• Type of Device: 7" SMALLBORE EXT. SET W/NEUTRON7" SMALLBORE EXT. SET W/NEUTRON
• 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: 5986604
• MDR Text Key: 55900126
• Report Number: 2025816-2016-00178
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• 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
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2021
• Device Model Number: NC107
• Device Catalogue Number: NC107
• Device Lot Number: 3238790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1