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

Model Number	65651-930C
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are pending, a follow up report will be submitted once the investigation has been completed.
Event or Problem 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.
Additional 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
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH JACKSONVILLE; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 6217780
• Report Number: 1423537-2017-00065
• Device Sequence Number: 19044905
• Product Code: GCX
• UDI-Device Identifier: 00885380028949
• UDI-Public: 00885380028949
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 65651-930C
• Device Catalogue Number: 65651-930C
• Device Lot Number: J609-322
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/06/2017
• Patient Sequence Number: 1
• Patient Age: 48 YR