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  Injury  

Manufacturer Narrative

It was reported during a liposuction procedure a suction canister exploded.During the procedure a cracking sound was heard from the suction canister and a crack was noted in the canister.The canister was removed and replaced, this incident repeated three more times during the procedure.The last canister used during the procedure exploded and bodily fluids splattered the ceiling, floor, suction machine, and the back table.The back table had to be torn down and re-set in a sterile manner causing a delay in the procedure.The surgeon discontinued use of the suction equipment and continued the procedure without further incident.It is unknown what the pressure settings were at the time of use.A sample was not returned and a root cause cannot be determined.Due to the reported incident and 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: 6499786
• MDR Text Key: 73009289
• Report Number: 1417592-2017-00018
• 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: Physician
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OR220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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