MAUDE Adverse Event Report: CARDINAL HEALTH JACKSONVILLE LINER 3000CC FLEX ADVANTAGE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-930C

Device Problems Air Leak (1008); Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are pending, a follow up report will be submitted once the investigation has been completed.

Event Description

Customer states liner is filling up with foam as soon as around 200 cc during paracentesis case.Tubing popped off and employee sprayed in face with contents.

Manufacturer Narrative

A review of the manufacturing device history record for the lot number provided (j609-322) was performed. the product was manufactured 09/07/2016. this investigation determined that all products were manufactured, inspected, and released in accordance with our established specifications for quality and efficacy.  no lot number was provided for the tandem tube.However, a review was performed for (b)(4) which is the portion of the tandem tube which interfaces with the flex liner.During the last three years there have been no non-conformances which would affect the retention of the tandem tube in the flex liner.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.The tandem tube connector which interfaces with the flex liner is tested as part of routine quality controls to ensure proper retention between the tandem tube and flex liner.This test is performed upon a representative sample retrieved from each production lot.The acceptance criteria for this test requires that each specimen sustain a force of 21 pounds or greater.This force exceeds the weight that a full liner would exhibit by a significant factor.Without the actual event sample involved in the customer incident and duplication of the non-conformance, we are unable to determine a specific assignable cause for the reported incident.As a quality control, a sample is taken from every production lot of tandem tube connectors.The sample is tested to determine the force required to remove the tandem tube connector from the lid of the flex liner.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions. key production and quality personnel have been made aware of this reported incident through the investigation process.  trending of past product quality reports indicate that this is the 1st reported incident for the tandem tube popping off with the flex advantage product line in the past three calendar years. no further action is planned at this time.

• Brand Name: LINER 3000CC FLEX ADVANTAGE
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH JACKSONVILLE; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): CARDINAL HEALTH JACKSONVILLE; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6217780
• MDR Text Key: 63955300
• Report Number: 1423537-2017-00065
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00885380028949
• UDI-Public: 00885380028949
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65651-930C
• Device Catalogue Number: 65651-930C
• Device Lot Number: J609-322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/01/2016
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR