MAUDE Adverse Event Report: BEMIS DE MEXICO, S.A. DE C.V. BEMIS QUICK-FIT 3000CC SUCTION LINER; SUCTION SYTEM CANISTER LINER

Model Number	3004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Similar device from the same lot has been received for analysis.Company representative is working to collect additional details from the user.Report will be updated when additional information is available.
Event or Problem Description
Facility reports difficulty putting flexible liners on hard canisters.When vacuum is on they seat, but when vacuum is turned off they pop off.Facility reports physician was splashed with fluid from canister.
Additional Manufacturer Narrative
Similar device from the same lot has been received for analysis.Company representative is working to collect additional details from the user.Report will be updated when additional information is available.Update: analysis of the returned sample indicated the fitment problem is due to a noncorming lid on the device.The nonconformance appears to be an outlier.Interview with representative of the user facility indicated that the splashing incident was not connected in any way with the fitment issue, and in the opinion of the user facility or staff, was most probably user error on part of physician.Attachment: [dhr review lot 174693.Pdf, (b)(4).Pdf].
Event or Problem Description
Facility reports difficulty putting flexible liners on hard canisters.When vacuum is on they seat, but when vacuum is turned off they pop off.Facility reports physician was splashed with fluid from canister.

• Brand Name: BEMIS QUICK-FIT 3000CC SUCTION LINER
• Common Device Name: SUCTION SYTEM CANISTER LINER
• Manufacturer (Section D): BEMIS DE MEXICO, S.A. DE C.V.; av. texas no. 200; parque industrial nacional; cienega de flores, nuevo leon 65550 ; MX 65550
• MDR Report Key: 8262358
• Report Number: 3011198121-2019-00001
• Device Sequence Number: 19326157
• Product Code: GCX
• UDI-Device Identifier: 00073088149541
• UDI-Public: 00073088149541
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K771737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019
• Report Date (Section F): 01/18/2019

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: 08/01/2021
• Device Model Number: 3004
• Device Catalogue Number: 3004
• Device Lot Number: 174693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1