MAUDE Adverse Event Report: MEDLINE INDUSTRIES; SUCTION CANISTER

Catalog Number OR220

Device Problems Burst Container or Vessel (1074); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

During a tummy tuck and liposuction a suction canister exploded expelling contents over the operating room (or) and surgical field.No one received an injury due to the canister exploding or the expelled contents.All staff was wearing appropriate personal protective gear including eye protection.No staff member had direct skin exposure to the expelled contents.No staff member was required to follow any exposure protocols or treatments.Expelled contents did not contaminate the surgical site.The procedure did not need to be stopped and the patient remained stable throughout.The patient was given an extra prophylactic antibiotic solution and is being monitored for post-op infection per facilities standard protocol.The investigation revealed that the facility inadvertently utilized the wrong suction canister for their suction device.The root cause was determined to be user-error.Due to the reported incident and in an abundance of caution, this medwatch is being filed.Device not returned.

Event Description

It was reported a suction canister exploded during a procedure.

• Type of Device: SUCTION CANISTER
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093 ; 8477703962
• MDR Report Key: 6280767
• MDR Text Key: 66146054
• Report Number: 1417592-2017-00001
• 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: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Outpatient Treatment Facility
• 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