MAUDE Adverse Event Report: CARDINAL HEALTH JACKSONVILLE CANISTER GUARDIAN 2000CC W/; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-220
Health Effect - Clinical Codes	Pain (1994); Vomiting (2144)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number was provided by the customer; therefore, a review of the manufacturing device history record to determine if any deviations took place during the manufacture of the product could not be performed.With the information provided, no specific assignable cause can be determined based on the product design or manufacturing conditions.If the canister had a crack before applying suction, this could prevent the unit from functioning as intended and could cause the unit to crack further during use.The actual event sample was not able to be provided by the customer; therefore, an evaluation of the actual complaint device for deficiency of construction could not be performed.However, ten samples were received from the customer for evaluation.A visual examination of the returned canisters was completed with production, engineering, and quality management.The canisters depicted various cracks in the rim, stacking lugs, and sidewall.Seven of the canisters were identified with cavity #1 and three were identified with cavity #2.Note: if the event sample is received at a later date and provides a different conclusion, an addendum report will be completed.Functional testing of nine of the returned samples was completed by our laboratory personnel (ltr t4329) to determine if the product meets the leak test requirements established with the iso 10079-3 standards.The canisters were found to be functionally acceptable according to our quality specifications.With the information provided, no specific assignable cause can be determined based on the product design or manufacturing conditions.If the canister had a crack before applying suction, this could prevent the unit from functioning as intended and could cause the unit to crack further during use.Per the directions for use included with the product, canisters, lids, and components should be inspected for damage from shipping, storage, or handling prior to use.Project jv17-007 is being reviewed to change the material of the canister form polystyrene to polypropylene which would help in the shipping damage.
Event or Problem Description
Based on information received from the customer the canisters plastic was fractured and did not provide adequate suction for the patient.Patient had a ng tube to low intermittent wall suction.Reportedly due to lack of poor suction the patient experienced vomiting, retching and pain.Patient was discharged on (b)(6) 2018.

• Brand Name: CANISTER GUARDIAN 2000CC W/
• 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: 7314780
• Report Number: 1423537-2018-00165
• Device Sequence Number: 16173001
• Product Code: GCX
• UDI-Device Identifier: 00630140152545
• UDI-Public: 00630140152545
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 65651-220
• Device Catalogue Number: 65651-220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 69