MAUDE Adverse Event Report: CARDINAL HEALTH MALTA 212 LTD FLEX ADVANTAGE LINER 3000ML; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651936

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.A review of the manufacturing device history record could not be conducted because the lot number was not provided.We have analysed the provided information, but with the limited information we cannot determine the specific cause for the reported concern.The sample was received and detailed investigation on the reported concern was conducted based on the sample received.A visual examination was completed by quality and engineering management and no non-conformance was noted on the unit received.The returned sample was tested by our laboratory for suction testing at a minimum vacuum pressure of -150 mmhg and a maximum vacuum pressure of -685 mmhg and the flex liner functioned as designed with both extremes vacuum pressures.The unit tested did seal hermetically to the outer canister and mechanical shut off valve rose up when flex advantage liner became full of fluids until eventually it came in contact with the under surface of the flex lid, closing the vacuum orifice and preventing further vacuum from entering the canister, thus stopping inflow of fluid waste.Further to that, the sample received was subjected to a leak test and it met the test requirements.This is the (b)(4) complaint received from this customer in regards with this reported concern.However, based on the investigation, we have concluded that the medi-vac flex advantage liner is free of defects or functional problems.Without a specific assignable cause and replication of the reported incident, no specific corrective action can be completed; however, we will continue to monitor concerns such as these for possible future action.Key production and quality personnel have been made aware of this reported incident through the investigation process.

Event Description

It was noticed a dysfunction of the vacuum system (suction interrupted) during the procedure.No report of patient injury, but a report that there was a delay in the procedure.

• Brand Name: FLEX ADVANTAGE LINER 3000ML
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer (Section G): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6945526
• MDR Text Key: 90334455
• Report Number: 1423537-2017-00130
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 65651936
• Device Catalogue Number: 65651936
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/22/2017
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1