MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY BEMIS 3000CC HIFLOW SUCTION CANISTER

Model Number	3002 055
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reviewed the device history records and found no discrepancies.The device was not returned for analysis.After interviewing the contact at the surgery center, it was determined the canister was used during a liposuction surgery.The instruction for use and canister label indicates not to use for liposuction.The root cause is due to user error.
Event or Problem Description
(b)(6) plastic surgery center reported a 3000cc suction canister cracked during a liposuction procedure.

• Brand Name: BEMIS 3000CC HIFLOW SUCTION CANISTER
• Common Device Name: SUCTION CANISTER
• Manufacturer (Section D): BEMIS MANUFACTURING COMPANY; w2940 old city pp; sheboygan falls WI 53085
• Manufacturer (Section G): BEMIS MANUFACTURING; w2940 old cty pp; sheboygan falls WI 53085
• Manufacturer Contact: karla quadracci ; w2940 old cty pp; sheboygan falls, WI 53085 ; 9204678995
• MDR Report Key: 14311216
• Report Number: 3000209940-2022-00001
• Device Sequence Number: 11931390
• Product Code: KDQ
• UDI-Device Identifier: 00073088149497
• UDI-Public: 073088149497
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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: 11/01/2024
• Device Model Number: 3002 055
• Device Catalogue Number: 3002 055
• Device Lot Number: 20210027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown