MAUDE Adverse Event Report: CARDINAL HEALTH CRD FLEX ADVANTAGE, 1 LT R?, 180CM, TUBE; CANISTER KIT

Model Number 65651916

Device Problems Decrease in Suction (1146); Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.The actual sample was received at our manufacturing site in february 2016 and a detailed investigation was conducted.A visual inspection was performed on the sample received and a dent in the middle part of the flexible liner was noted.The sample was subjected to a flow test to determine if it will function once vacuum pressure is applied and it met the test requirements at both minimum vacuum pressure of -400mmhg and high pressure of -700mmhg.Consequently the liner was subjected to a functional test and no fluid leaks were observed.The unit tested did seal hermetically to the outer canister and mechanical shut off valve rose up when flex advantage liner became full with 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.It is to be noted that a hole or dent on the flexible liner will have no effect on the functionality of the device since the intended use of the flexible bag is to provide reservoir to the collected fluid.Based on the investigation, we have concluded that the dent on the flexible liner has no effect on the form, fit and functionality of the device.We concluded that medi-vac flex advantage liners are free of defects or functional problems.A review of the manufacturing device history record for the referenced lot number was completed.No non-conformance with regard to ¿suction failure¿ or ¿hole in liner¿ was noted.The investigation determined that all products were manufactured, inspected and released in accordance to our established specification for quality and efficacy.We will continue to monitor for similar reports.

Event Description

The nurse attempted emergency aspiration on a baby suffering from a respiratory tract infection.There was no suction because the liner had a hole in it.A new liner was used and worked as intended.

• Brand Name: CRD FLEX ADVANTAGE, 1 LT R?, 180CM, TUBE
• Type of Device: CANISTER KIT
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL
• Manufacturer (Section G): CARDINAL HEALTH MALTA 212 LTD; a51 industrial estate; marsa, marsa MRS30 00; MT MRS3000
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5501517
• MDR Text Key: 40577538
• Report Number: 1423537-2016-00012
• 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,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 65651916
• Device Catalogue Number: 65651916
• Device Lot Number: 15I06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention