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

Model Number N/A

Device Problem Fire (1245)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information was 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 product insert has instructions not to use cavilon no sting barrier film near sources of ignition or when heat-producing devices are in use.The instructions for use include the following: warnings 1.Danger! highly flammable! 2.Cavilon no sting barrier film is highly flammable until it has completely dried on the skin.3.Cavilon no sting barrier film should only be applied when no ignition sources or heat-producing devices are in use.4.Avoid using around flames.5.Use in a well-ventilated area.

Event Description

A procedure was performed for an excision of a pilonidal cyst, during which 3m cavilon no sting barrier film was applied in preparation for a wound vac application.After cavilon was applied, the surgeon noticed a small bleed and attempted to cauterize it with a bovie cautery instrument, where there most likely was not 90 seconds between the application of 3m cavilon no sting barrier film and use of the cautery instrument.A brief flash fire occurred.No patient injury was reported.

• Brand Name: 3M CAVILON NO STING BARRIER FILM
• Type of Device: 3M¿ CAVILON¿ NO STING BARRIER FILM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTH CARE LIMITED; 3m health care limited; derby road; loughborough, united kingdom LE11 5SF; UK LE11 5SF
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 11729559
• MDR Text Key: 249682558
• Report Number: 2110898-2021-00029
• Device Sequence Number: 1
• Product Code: KMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3343
• Date Manufacturer Received: 04/13/2021
• 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