MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY BEMIS HIFLOW SUCTION CANISTER 1200CC

Model Number 480410

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

Product was made 05/2011 and is three years passed it's marked expiration date (05/2014.) excessive uv exposure causes oxidation and embrittlement of the plastic.Bemis has implemented a 3 year (35 month) expiration date since 2007, and has included a uv inhibitor/antioxidant since 2012.Customer has been advised to inspect all of their code carts for expired canisters and replace them.

Event Description

Customer reported that during a routine check out of a code cart, the canister imploded after turning on the cart suction.

• Brand Name: BEMIS HIFLOW SUCTION CANISTER 1200CC
• Type of Device: SUCTION CANISTER
• Manufacturer (Section D): BEMIS MANUFACTURING COMPANY; w2940 old cty pp; sheboygan falls WI 53085 0901
• Manufacturer (Section G): BEMIS MANUFACTURING COMPANY; w2940 old cty pp; sheboygan falls WI 53085 0901
• Manufacturer Contact: john cutting ; w2940 old cty pp; sheboygan falls, WI 53085-0901 ; 9204678927
• MDR Report Key: 6676539
• MDR Text Key: 78697954
• Report Number: 2133713-2017-00003
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Expiration Date: 04/01/2014
• Device Model Number: 480410
• Device Lot Number: 20110509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1