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

Catalog Number OR220

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported during a liposuction procedure the suction canister exploded; expelling biological materials over walls and staff.All staff was wearing appropriate personal protective gear including eye protection.The procedure continued as the surgical team cleaned the area of expelled contents.The procedure was done with a local anesthetic and no time was added to the procedure.The patient remained stable throughout the incident and no injury occurred.Samples were received and evaluated.Visual inspection showed some canisters were cracked and lids were from various manufacturers.Root cause has not been determined, we cannot rule out incorrect storage by end-user.Due to the reported incident an in an abundance of caution this medwatch is being filed.

Event Description

It was reported 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 ; 8477703962
• MDR Report Key: 6425430
• MDR Text Key: 70877349
• Report Number: 1417592-2017-00017
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OR220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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