MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER; 4-WAY STOPCOCK WITH ROTATING MALE LUER LOCK

Catalog Number 2C5601

Device Problems Break (1069); Sticking (1597); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2013

Event Type  malfunction  

Event Description

Patient came from the operating room (or) with intravenous (iv) tubing.The nurse (rn) was changing the iv tubing in order to place on a pump at the bedside.The tubing the patient arrived with had two stopcocks.As rn attempted to disconnect the tubing from the stopcocks to hook up new tubing, the plastic tubing that connected the two stopcocks together broke, leaving a piece of plastic stuck inside the tubing.Rn unhooked both stopcocks so that new tubing could be connected to the iv.The patient was not harmed.

• Brand Name: BAXTER
• Type of Device: 4-WAY STOPCOCK WITH ROTATING MALE LUER LOCK
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 3628569
• MDR Text Key: 4181264
• Report Number: 3628569
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 2C5601
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Patient Sequence Number: 1
• Patient Age: 11 YR