MAUDE Adverse Event Report: 3M HEALTH CARE LIMITED 3M CAVILON NO STING BARRIER FILM 3343E; 3M¿ CAVILON¿ NO STING BARRIER FILM 3343E

Model Number N/A

Device Problem Fire (1245)

Patient Problem Not Applicable (3189)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: no information was provided.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.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.

Event Description

A eu regulatory authority reported on (b)(6) 2019 a employee was using 3m¿ cavilon¿ no sting barrier film 3343e in a hospital.While using the cavilon stick, the empty package was on the shelf at bedside.The employee was wearing gloves and removed the slide sheet from under a patient.The employee proceeded to pick up the empty cavilon packaging and heard a sizzle and small flames appeared.The flames went out immediately.No one was injured.

• Brand Name: 3M CAVILON NO STING BARRIER FILM 3343E
• Type of Device: 3M¿ CAVILON¿ NO STING BARRIER FILM 3343E
• Manufacturer (Section D): 3M HEALTH CARE LIMITED; derby road; loughborough leicestershire, gb
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, mn ; 7379117
• MDR Report Key: 9740776
• MDR Text Key: 180395207
• Report Number: 2110898-2020-00010
• Device Sequence Number: 1
• Product Code: KMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K955103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 3343E
• Device Lot Number: 2022-07 AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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