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

Model Number 1504RBM N

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

This is the 4th medwatch report for similar event.Specifically: liners collapsed and leaked at the corner of the liner, creating a mess of fluid inside tubing and hard canister.This occurred twice in the same day.Also contaminated suction tubing.This report is capturing the information realted to the recent event on 9/1/2022.Then liner lot sizes are 20,000 and sold to many customers.This is the only complaint received for this lot.The source of the leak could not be identified as the result of our investigation.

Event Description

Carmel valley facial plastic surgery reported that the liners collapsed and leaked at the corner of the liner, creating a mess of fluid inside tubing and hard canister.This occurred twice in the same day.Also contaminated suction tubing.

• Brand Name: BEMIS 1500CC QUICK-FIT CANISTER LINER
• Type of Device: SUCTION LINER
• Manufacturer (Section D): BEMIS DE MEXICO; av texas #200; parque industrial nacional; cienegra de flores, nl, mex 65550 ; MX 65550
• Manufacturer (Section G): BEMIS DE MEXICO; av texas #200; parque industrial nacional; cienegra de flores, nl 65550 ; MX 65550
• Manufacturer Contact: rodolfo villarreal ; av texas #200; parque industrial nacional; cienegra de flores, nl 65550 ; MX 65550
• MDR Report Key: 15761591
• MDR Text Key: 307708777
• Report Number: 3011198121-2022-00006
• Device Sequence Number: 1
• Product Code: GCX
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504RBM N
• Device Catalogue Number: 1504RBM N
• Device Lot Number: 204371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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