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 Not Applicable (3189)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The flammability event is not due to a product defect or problem with this specific lot.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.Based on information provided in the incident report, the ignition source for this flammability event is believed to be potential static electricity discharge.The product insert has instructions not to use cavilon no sting barrier film near sources of static discharge.The instructions for use include the following: warnings: danger! highly flammable! cavilon no sting barrier film is highly flammable until it has completely dried on the skin.Cavilon no sting barrier film should only be applied when no ignition sources or heat-producing devices are in use.Avoid using around flames.Use in a well ventilated area.The device was manufactured on january 16, 2019.Complaint was reported to 3m via medwatch mw5095265.

Event Description

Procedure for debridement of right hip wound; near the end of the procedure, the surgeon requested the staff member to apply cavilon barrier film around the incision.After application of the cavilon, the surgeon bovie pencil in the surgical area at which time there was a flash flame.Fire was contained and extinguished and there was no injury to the patient 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
• 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 ; 7379117
• MDR Report Key: 10310332
• MDR Text Key: 199934923
• Report Number: 2110898-2020-00034
• Device Sequence Number: 1
• Product Code: KMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 3343E
• Device Lot Number: 139109A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2020
• 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