MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC EP ANGIO II PACK CUSTOM; TUBING, PRESSURE, FLUID DELIVERY

Lot Number 14QB0362

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

Leak in one of the pressure tubing.Pack comes with 5 pressure tubings.No visual defects to device or packaging prior to use.New pressure tubing obtained and case continued.No harm.

• Brand Name: EP ANGIO II PACK CUSTOM
• Type of Device: TUBING, PRESSURE, FLUID DELIVERY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; 1 medline place; mundelein, IL 60060
• MDR Report Key: 4180117
• MDR Text Key: 5088425
• Report Number: 4180117
• Device Sequence Number: 1
• Product Code: BYX
• 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: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 14QB0362
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIAC ABLATION SET-UP