MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. T CONNECTOR; STOPCOCK, I.V. SET

Catalog Number MX2311L

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2013

Event Type  malfunction  

Event Description

Stopcock broken with the white turning portion of the stopcock completely out of device.Removed from patient and placed in bag.Lines replaced.No apparent patient harm.No visual defect and no way to detect failure prior to event.

• Brand Name: T CONNECTOR
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 4195439
• MDR Text Key: 4968080
• Report Number: 4195439
• Device Sequence Number: 1
• Product Code: FMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/07/2014

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
• Device Operator: Nurse
• Device Catalogue Number: MX2311L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2014
• Patient Sequence Number: 1
• Patient Age: 23 DAY