MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY BEMIS 3000CC HI-FLOW SUCTION CANISTER

Model Number 3002 055

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

Failed device not available for return, and no inventory of reported lot remains.Dhr reviewed, no discrepancies found.

Event Description

Complainant stated that the bottom of a 3000 cc canister 'blew out' during an operating room case.There was no exposure to contents, and no patient consequences.

• Brand Name: BEMIS 3000CC HI-FLOW 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: 5573922
• MDR Text Key: 42545255
• Report Number: 2133713-2016-00002
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: 3002 055
• Device Catalogue Number: 3002 055
• Device Lot Number: 20151214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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