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

Model Number N/A

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

A1, a4- a6: no information was provided.H10: the product was not returned for analysis and a lot number was not 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.

Event Description

A flammability event was reported with use of 3m¿ cavilon¿ no sting barrier film wipes when applied to the perimeter of an abdominal wound by the first assist (fa) during a wound v.A.C.Application procedure (3m¿ v.A.C.® ulta therapy unit).At the time that cavilon was applied, the surgeon used a bovie electrocautery tool (type unspecified) which ignited on the patient's abdomen; a small fire started near the edge of the wound where the cavilon was applied.The cavilon that was used was from a 3m¿ veraflo¿ kit.The surgical team quickly extinguished the fire using a laparotomy sponge soaked in puracyn® and normal saline.The surgeon reported a superficial burn to the lower border of the wound.The surgeon applied a mepilex® transfer dressing to the affected area and completed the wound vac application.The patient was discharged home on (b)(6) 2024, on a 3m¿ activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring.A 3m representative met with the or director, coo, patient safety, or educator, and the surgeon on (b)(6) 2024 and went over the product ifu and discussed the education refresher plan for the or staff and surgeons.

• 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 1000
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 56144-1000
• MDR Report Key: 18577040
• MDR Text Key: 333658451
• Report Number: 2110898-2024-00001
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• 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
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female