MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE CONNECTOR

Model Number 12568

Device Problems Connection error (1116); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2014

Event Type  malfunction  

Event Description

Maude event report received concerning attachment issues with use of 12568 microclave connector and a "y-type microbore extension set.".The maude report states "multiple issues with microclave connector becoming disconnected during routine patient care.During one of these events, a microclave (lot# 35-455-jw) popped off a y-type microbore extension set that was a transfuse iv fluids via pcvc line." there were no reported adverse patient consequences.Additional incident information including identity of involved mating devices, and status of device set-up return has been requested.As of the date of this report there has been no response.Manufacture's investigation: records review of the mfg lot build database for the reported lot# 35-455-jw (mfg date 11-2013) shows (b)(4) units were mfg, tested, inspected and released.There were no exception documents generated during the mfg lot build.A two year review of the complaint database for this list#/lot# recorded no additional reports.

Manufacturer Narrative

Findings: the exact cause (s) of the reported product experiences/issues are unknown.

• Brand Name: MICROCLAVE CONNECTOR
• Type of Device: MICROCLAVE CONNECTOR
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3771178
• MDR Text Key: 4376090
• Report Number: 2025816-2014-00041
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2014,02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12568
• Device Catalogue Number: 12568
• Device Lot Number: 35-455-JW
• Other Device ID Number: PR# 24074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2014
• Distributor Facility Aware Date: 01/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2014
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: Y-TYPE MICROBORE EXTENSION SET, MFG MAKE MODEL UNK