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 02/03/2022

Event Type  malfunction  

Event Description

A customer reported that after completing a colonoscopy procedure the nurse noticed the 1500cc liner leaked suctioned content into the outer hard canister.

Manufacturer Narrative

Phone call with customer determined this is a single event.The source of the leaking could not be identified.

• 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, nl 65550 ; MX 65550
• Manufacturer Contact: rodolfo villarreal ; av texas #200; parque industrial nacional; cienega de flores, nuevo leon 65550 ; MX 65550
• MDR Report Key: 14316439
• MDR Text Key: 299760501
• Report Number: 3011198121-2022-00002
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2022

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
• Device Lot Number: 202071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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