MAUDE Adverse Event Report: CARDINAL HEALTH LINER 3000CC FLEX ADVANTAGE; COMMON NAME SUCTION LINER

Model Number 65651-930C

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/17/2014

Event Type  Injury  

Event Description

The report refers to the anti-reflux unidirectional valve (patient port), by which the aspirated content of the procedure was expelled with pressure, also at the moment of handling before disposal by the user.The event was considered severe since the content had direct contact with the user when spilled on this person's face and eye area.We (distributor) visited the operating room and verified that the failure in the valve was not due to an error in the handling of the product, and we also corroborated that the content was expelled from the unidirectional valve (patient port) but not with pressure, rather slipping slowly through it.We did not observe errors in the handling of the product by the users.

Manufacturer Narrative

No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Previous discussions with the (b)(4), and the sales representative were conducted regarding the reported issue.It was determined that reflux issues were due to the customer turning off the vacuum prior to capping.The cardinal team explained the proper procedure for the disposal process as outlined in the instructions for use and that the reflux valve is a safety feature and not intended to be a hermetic seal.Note: if the event sample is received at a later date and provides a different conclusion, a follow-up report will be submitted.

• Brand Name: LINER 3000CC FLEX ADVANTAGE
• Type of Device: COMMON NAME SUCTION LINER
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 4491670
• MDR Text Key: 18918504
• Report Number: 1423537-2015-00007
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 65651-930C
• Device Catalogue Number: 65651-930C
• Device Lot Number: 404-360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 95