MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. CARDIOVASCULAR PACK; TUBING, NONINVASIVE

Lot Number 14WB6301

Device Problems Contamination (1120); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2015

Event Type  No Answer Provided  

Event Description

This was tubing that is contained in a pack when attaching the pressure tubing to the manifold.When flushing, it was noticed that the tube was leaking.It seemed it was coming from the male end of tubing where the tubing joins the connector.This all took place before patient came in the room.The tubing was replaced from catheter lab stock tubing and worked fine.

• Brand Name: CARDIOVASCULAR PACK
• Type of Device: TUBING, NONINVASIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 4612278
• MDR Text Key: 5635196
• Report Number: 4612278
• Device Sequence Number: 1
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Other
• Device Lot Number: 14WB6301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2015
• Patient Sequence Number: 1