MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SUCTION CANISTER

Catalog Number OR220

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts have been made to contact the account for additional details with no response.The original report stated "the bottom of the canister blew out." there are many unknowns with this incident including but not limited to the type of procedure performed, how long the suction was in use, type of suction machine being used, and the storage conditions of the canisters.A sample was returned and the complaint confirmed.Root cause could not be determined.Due to the reported incident and in an abundance of caution this report is being filed.

Event Description

It was reported that a suction canister exploded during use.

• Type of Device: SUCTION CANISTER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093
• MDR Report Key: 6587198
• MDR Text Key: 76022297
• Report Number: 1417592-2017-00041
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OR220
• Device Lot Number: 68116111712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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
• Patient Outcome(s): Other