MAUDE Adverse Event Report: ICU MEDICAL MICROCLAVE NEUTRAL CONNECTOR

Catalog Number	12568
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The med tubing had a small crack and was leaking at the clave.

• Brand Name: MICROCLAVE NEUTRAL CONNECTOR
• Common Device Name: MICROCLAVE NEUTRAL CONNECTOR
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8639940
• Report Number: 8639940
• Device Sequence Number: 14028235
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: 0100887709042377
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2019
• Report Date (Section F): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 12568
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 DA
• Patient Weight: 1
• Date Report Sent to FDA: 05/16/2019