MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY BEMIS HIFLOW SUCTION CANISTER 2000CC

Model Number	494410
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	11/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer provided laser engraved manufacturing date and information from canister cover which was subsequently traced to reported model and production date.No inventory existed of that sku, but canister covers from same period existed in other inventory.Product was tested for both airflow and actual function.No issues were found with either.Dhr review found no issues.Sample was disposed of by user and not available for analysis.We have not received any similar complaints.We cannot confirm this complaint.Product not returned for analysis.
Event or Problem Description
Patient needed aspiration and suction did not work.

• Brand Name: BEMIS HIFLOW SUCTION CANISTER 2000CC
• Common Device Name: SUCTION CANISTER
• Manufacturer (Section D): BEMIS MANUFACTURING COMPANY; w2940 old county pp; sheboygan falls WI 53085 0901
• MDR Report Key: 6289883
• Report Number: 2133713-2017-00001
• Device Sequence Number: 1564142
• Product Code: KDQ
• UDI-Device Identifier: 00073088150042
• UDI-Public: (01)00073088150042(17)190901(10)20160026
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/30/2017

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: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: 494410
• Device Lot Number: 20160026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1