MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MAJOR PACK

Catalog Number	DYNJ31206D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that there was an arch during an unknown procedure and it caused a small fire.There was no patient impact and no property damage reported.Numerous attempts have been made to attempt to contact the facility to obtain additional information related to the incident; however no additional details were available.There was no injury reported.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No additional information is available.A sample was returned for evaluation and found no damage to the casing, cord or plug.There were no indications of burning or charring to the body or receptacle of the component.Issue appears to most likely be cause from not cleaning cautery blades during use.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that there was an arch during a case and it caused a small fire.No patient impact was reported.

• Common Device Name: MAJOR PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7182058
• Report Number: 1423395-2017-00032
• Device Sequence Number: 16639004
• Product Code: GEI
• UDI-Device Identifier: 10889942654260
• UDI-Public: 10889942654260
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJ31206D
• Device Lot Number: 17UB0355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1