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

Model Number	N/A
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier-race information was not provided.This complaint is for a flammability event that occurred in (b)(6) 2019.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 will occur if the product is exposed to an ignition source before the vapors are dissipated.There is flammability information in cavilon¿ no sting barrier film ifus and a flame symbol on each individual pouch.For this application, cavilon¿ no sting barrier film catalog number 3344ens is provided non-sterile to kci as a component of their kit.It is unclear if the cavilon¿ no sting barrier film flammability symbol could be seen in the kit.Cautery was the ignition source for this event.The root cause of the flammability event is cautery ignited cavilon¿ no sting barrier film vapors.
Event or Problem Description
(b)(6) reported to 3m that during the installation of a vac in the operating room, a vac veraflo¿ kit and a veraflo¿ choice dressing was used.The operator reportedly put down the 3m¿ cavilon¿ no sting barrier film (3344e) and the wipe ignited following use of an electrosurgical knife nearby.No injuries were reported.No medical treatment to patient was required.

• Brand Name: 3M¿ CAVILON¿ NO STING BARRIER FILM
• Common Device Name: CAVILON NO STING BARRIER FILM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9413474
• Report Number: 2110898-2019-00144
• Device Sequence Number: 2934394
• Product Code: KMF
• UDI-Device Identifier: 30707387782376
• UDI-Public: 30707387782376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 3344
• Device Lot Number: 616725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VAC VERAFLO¿ KIT; VERAFLO¿ CLEANSE CHOICE DRESSING
• Outcome Attributed to Adverse Event: Life Threatening