MAUDE Adverse Event Report: BEMIS DE MEXICO, SA DE CV BEMIS QUICK FIT 1500CC SUCTION LINER; SUCTION SYSTEM CANISER LINER

Model Number	1504
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempting to get sales rep to meet with complainant.Complainant not responding to date.
Event or Problem Description
Customer reports that they had a suction liner with a tear in it as they prepared to remove it from the canister, allowing for suctioned contents to spill into the canister.

• Brand Name: BEMIS QUICK FIT 1500CC SUCTION LINER
• Common Device Name: SUCTION SYSTEM CANISER LINER
• Manufacturer (Section D): BEMIS DE MEXICO, SA DE CV; av texas #200; parque industrial nacional; cienega de flores, 65550 ; MX 65550
• MDR Report Key: 9130827
• Report Number: 3011198121-2019-00003
• Device Sequence Number: 2376953
• Product Code: GCX
• UDI-Device Identifier: 00073088149213
• UDI-Public: 0073088149213
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K771737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/27/2019
• Report Date (Section F): 09/05/2019

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: 03/20/2022
• Device Model Number: 1504
• Device Catalogue Number: 1504
• Device Lot Number: 179890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2019
• Device Age: 4 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1