MAUDE Adverse Event Report: BEMIS DE MEXICO BEMIS 1500CC QUICK-FIT SUCTION LINER

Model Number	1504RBM N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Caremount medical p.C.Had two more events of the bemis liner 1504rbm n leaking suctioned contents into the outer hard canister.This report is for the event on 4/5/22 lot 202605.
Additional Manufacturer Narrative
This is the second occurrence reported to bemis for a 1500cc liner leak.There were two liners that leaked suctioned content into the outer canister.This report is capturing the information from the event on 4/5/2022 lot 202605.The other liner leaked on 3/31/22 and that lot number could not be confirmed.The liner lot size are 20,000 and are sold to many customers and this is the only complaint received.The source of the leak could not be identiited.

• Brand Name: BEMIS 1500CC QUICK-FIT SUCTION LINER
• Common Device Name: SUCTION LINER
• Manufacturer (Section D): BEMIS DE MEXICO; av texas #200; parque industrial nacional; cienega de flores, nl 65550 ; MX 65550
• Manufacturer (Section G): BEMIS DE MEXICO; av texas #200; parque industrial nacional; cienega de flores, nuevo leon 65550 ; MX 65550
• Manufacturer Contact: rodolfo villarreal ; av texas #200; parque industrial nacional; cienega de flores, nl 65550 ; MX 65550
• MDR Report Key: 14316738
• Report Number: 3011198121-2022-00003
• Device Sequence Number: 4677062
• Product Code: GCX
• UDI-Device Identifier: 00073088159533
• UDI-Public: 073088159533
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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: 12/10/2024
• Device Model Number: 1504RBM N
• Device Lot Number: 202605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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