MAUDE Adverse Event Report:; STOPCOCK, I.V. SET

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 09/04/2019

Event Type  malfunction  

Event Description

At start of shift assessment found 5-way gang (from operating room) cracked and leaking fluid/drops-per-minute (gtts) into bed.Gang replaced with 7 port nanoclave manifold replaced with new fluids, gtts and lines.Operating room to stock and replace all gangs with 7 port nanoclave manifold.

• Type of Device: STOPCOCK, I.V. SET
• MDR Report Key: 9151728
• MDR Text Key: 161073860
• Report Number: 9151728
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1