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

Model Number 65651-220

Device Problems Fracture (1260); Suction Problem (2170)

Patient Problems Pain (1994); Vomiting (2144)

Event Date 01/25/2018

Event Type  Injury  

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 (b)(4) 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 (b)(4) is being reviewed to change the material of the canister form polystyrene to polypropylene which would help in the shipping damage.

Event 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 set 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/
• 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: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7314771
• MDR Text Key: 101564309
• Report Number: 1423537-2018-00164
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00630140152545
• UDI-Public: 00630140152545
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

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