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

Model Number 1504RBM N

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

This is the second notification reported to bemis for a 1500cc liner leak.There were two liners that caremount reported leaked.One on (b)(6) 2022 and the other on (b)(6) 2022.This report is for the event occurred on (b)(6) 2022 and there was no lot number provided.The liner lot size are 20,000 and are sold to different customers.This is the only customer complaint received.The source of the lak cannot be determined.

Event Description

Caremount medical p.C.Had another event of the bemis liner 1504rbm n leaking suction contents into the outer hard canister.

• Brand Name: BEMIS 1500CC QUICK-FIT SUCTION LINER
• Type of Device: 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, nuevo leon 65550 ; MX 65550
• MDR Report Key: 14316336
• MDR Text Key: 299618158
• Report Number: 3011198121-2022-00004
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00073088159533
• UDI-Public: 073088159533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K771737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504RBM N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1