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

Catalog Number OR220

Device Problems Break (1069); Burst Container or Vessel (1074)

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

Event Type  malfunction  

Manufacturer Narrative

During a procedure, the bottom of a suction canister exploded and the canister flew off the holder and broke on the floor.The contents were expelled over the ceiling, three walls, and the floor of the surgical suite.Due to the expelled contents the patient had to be moved to a clean surgical suite to complete the procedure, causing a delay.No staff member was injured.No staff member was required to follow any exposure protocols or treatments.It is unknown if the suction canister is compatible with the suction device used.A sample was not returned.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 a procedure.

• 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: 6383699
• MDR Text Key: 69511158
• Report Number: 1417592-2017-00014
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• 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: Ambulatory Surgical Facility
• Date Manufacturer Received: 02/17/2017
• 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