MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; CANISTER,RIGID,DISPOSABLE,2000CC

Catalog Number OR220

Device Problems Burst Container or Vessel (1074); Crack (1135); Chemical Spillage (2894)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a liposuction procedure, the suction canister exploded in the middle of a case, cracking, and causing the contents to spill out.The facility reported that the canister was inspected prior to use.No one received an injury due to the canister exploding and there was no reported direct skin contact with any of the staff and the expelled contents.All of the staff was wearing appropriate personal protective gear including eye protection.No staff member was required to follow any exposure protocols or treatments.Expelled contents did not contaminate the surgical site.The procedure was stopped however there was no impact to the patient's stability or the procedure being performed.A sample was not returned for evaluation.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: CANISTER,RIGID,DISPOSABLE,2000CC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES INC; three lakes dr.; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes dr; northfield, IL 60093 ; 8476434960
• MDR Report Key: 6866878
• MDR Text Key: 86437301
• Report Number: 1417592-2017-00067
• 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
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: OR220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1