MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE

Model Number 011-C3300

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of lot# 2956054 showed that (b)(4) units were manufactured, tested, inspected, and released citing no exception documents.Visual analysis: 1/31/2017 - received one used 011-c3300, microclave, reported lot # 2956054.No mating devices were returned.The threads of the male luer was confirmed to be cracked and separated from the microclave body.The male luer was not returned.Functions testing: one used 011-c3300 microclave was returned with the male luer broken and missing and the male luer threads broken.The break exhibited a brittle fracture.There was a mating device thread track mark on the female luer end of the 011-c3300 microclave adjacent to the thread stop.There were no other mechanical marks on the 011-c3300 microclave that were observed.Final analysis summary: the complaint of a used 011-c3300 microclave being broken at the male luer end was confirmed.The break was brittle in nature and is typical of environment stress cracking during use.Icu medical will continue to monitor and trend.

Event Description

Complaint received regarding one 011-c3300, microclave, lot # 2956054 (mfd.11/14).Report states, during use of the needlefree connector, a part of the device snapped off and got stuck within the patients line.An attempt was made to remove it but it caused the line to fracture.As a result, the patient needed emergency surgery to replace the line.Med/surg intervention reported.No other adverse patient consequences reported.

• Brand Name: MICROCLAVE
• Type of Device: MICROCLAVE
• 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: 6305666
• MDR Text Key: 66672585
• Report Number: 2025816-2017-00034
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/01/2019
• Device Model Number: 011-C3300
• Device Catalogue Number: 011-C3300
• Device Lot Number: 2956054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2017
• 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