MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ CAVILON¿ NO STING BARRIER FILM

Model Number	N/A
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: date of event not provided.The product was not returned for analysis and no lot number was provided.The product is flammable until it is completely dry and vapors have dissipated.A flammability event may occur if the product is exposed to an ignition source before the vapors are dissipated.The instructions for use include the following: warnings: 1.Danger! extremely flammable! 2.Cavilon no sting barrier film contains hexamethyldisiloxane which is considered extremely flammable.3.Cavilon no sting barrier film is extremely flammable until it has completely dried on the skin and vapors have dissipated.Allow the product to dry for a minimum of 90 seconds before using any device that could provide a source of heat or ignition.This allows fluid to dry and vapors to dissipate.4.Do not use cavilon no sting barrier film near fire or flame, heat, sparks and sources of static discharge.5.Do not use cavilon no sting barrier film near ignition sources or heat-producing devices.Use in a well ventilated area.6.Foam applicators and wipes are individually packaged for single use only.Reuse could result in increased risk of infection, or inadequate product performance.The spray bottle is intended for single patient use.7.Keep out of the reach of children.End of report.
Event or Problem Description
A flammability event was reported with use of 3m cavilon no sting barrier film applied after surgery that was not completely dry during application of a wound vac and a flash of fire occurred quickly with no injury to the patient.No additional information was provided upon follow-up attempts with the facility.

• Brand Name: 3M¿ CAVILON¿ NO STING BARRIER FILM
• Common Device Name: 3M¿ CAVILON¿ NO STING BARRIER FILM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): APHENA PHARMA SOLUTIONS; 7978 industrial park road; easton MD 21601
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6517379117
• MDR Report Key: 15178387
• Report Number: 2110898-2022-00055
• Device Sequence Number: 20101785
• Product Code: KMF
• UDI-Device Identifier: 30707387509768
• UDI-Public: 30707387509768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K955103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3345
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown