MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CRD FLEX 1500CC CANISTER WITH VALVE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65652-616A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was received by cardinal health for this reported incident.A team from engineering and quality reviewed the information received from the customer.Based on the limited information provided by the customer, it is believed that the separation of the bottom from the canister is a result of the cleaning agents used on the canister.Typically, a failure mode like this is caused when the canister is exposed to harsh cleaning agents that are contra indicated.These chemicals will degrade the material and cause breakage.Without a sample a definitive cause cannot be given.No further action required at this time.
Event or Problem Description
During induction of a patient, the receptacle of the outer suction jar gave way, rendering the suction non-functional.The suction was correctly mounted and the vacuum network depression was less than 800 mbar.

• Brand Name: CRD FLEX 1500CC CANISTER WITH VALVE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 10646067
• Report Number: 1423537-2020-00539
• Device Sequence Number: 19573805
• Product Code: GCX
• UDI-Device Identifier: 50885380158597
• UDI-Public: 50885380158597
• Combination Product (Y/N): N
• Initial Reporter Country: RE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: No Information
• Device Model Number: 65652-616A
• Device Catalogue Number: 65652-616A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1