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

Model Number 480410

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Product was two years and three months past its expiration date.Informed customer that they should review any installations in their facility for expired product and remove and replace.

Event Description

Complainant stated that when staff was testing a canister it imploded.There was no patient involvement, and no injury.

• Brand Name: BEMIS 1200CC HIFLOW SUCTION CANISTER
• 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: 5676982
• MDR Text Key: 45836137
• Report Number: 2133713-2016-00004
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Model Number: 480410
• Device Catalogue Number: 480410
• Device Lot Number: 20110321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2011
• 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