MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,HOT,INSTANT,DLX,NONWOVEN,6" X 8"

Catalog Number	MDS149000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by the director, occupational and environmental safety, (b)(6) university and medicine with additional information in regards to this incident.Reporter states the incident occurred (b)(6) 2020, "a custodian pulled a trash bag and set it on the floor.She turned around to get another bag and heard a loud pop.When she turned back around, the bag on the floor was on fire.Upon seeing the bag on fire, the custodian alerted the unit staff.One arrived and put out the fire with an extinguisher." reporter states the fire department arrived on scene and an investigation was conducted.There are no reports of injury, serious injury or medical intervention reported by the facility or the facility contact.Fire department incident number (b)(4).Fire department report reads as follows, "examination of the area and contents revealed an irregular burn pattern on the floor.Affixed to this was the remnants of a heating pad.There was a large amount of discarded alcohol pads.The fire was contained to the contents of the trash bag before it was extinguished.After collecting and analyzing the data.The following hypothesis was developed.The employee removed the trash bag from the can, placed it on the floor, and tied it.The discarded heating pad ignited the vapors from the alcohol pads.This created a small-pressurized flash fire.This explained the small explosion that was described by the witness.This hypothesis is consistent with the known facts collected at the scene." the fire department investigation conclusion reads as follows, "it is this investigators opinion that this fire was the result combustibles to close to a heat source." no sample is available for return and evaluation.No further information is available.Due to the reported nature of the incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental med watch will be filed.
Event or Problem Description
It was reported a fire was suspected of resulting from an instant hot pack being disposed of in the same trash bag as several alcohol prep pads.

• Common Device Name: PACK,HOT,INSTANT,DLX,NONWOVEN,6" X 8"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10757137
• Report Number: 1417592-2020-00114
• Device Sequence Number: 1125575
• Product Code: IMD
• UDI-Device Identifier: 00080196749891
• UDI-Public: 00080196749891
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS149000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention