MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-08-16 for CAVILON NO STING BARRIER FILM 3345 manufactured by 3m Health Care.
[52652638]
On 08/09/2016 date 3m management made the internal decision to file mdr report for this complaint. (b)(4). 3m completed a retrospective complaint review. This report 2110898-2016-00080 is now being filed with the fda due to similar reports where an injury occurred. There was no patient injury associated with this report. 3m is in the process of a packaging update. In addition to the current packaging warnings, a red flame symbol has already been added to 3346 packaging and will be added to 3343 and 3344 packaging. Current packaging states the following: warning! Extremely flammable caution, see instructions for use instructions for use state the following warning: cavilon no sting barrier film is extremely 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. Instructions for use in a surgical setting: refer to the warnings section of this information. When used in a surgical environment, use of cavilon no sting barrier film should be discussed during the "time out" period for verification of surgical procedure and site.
Patient Sequence No: 1, Text Type: N, H10
[52652639]
Customer reported 3345 cavilon no sting barrier film was applied to a (b)(6) male trauma patient undergoing abdominal surgery on (b)(6) 2016. Cautery was reportedly used on a bleeder before the cavilon no sting barrier film was allowed to dry and as a result, there was a vaporization flash/flame. Customer reported there was no harm to the patient or staff. Facility reported staff education was completed and no further follow-up training by 3m local representative was needed at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00080 |
| MDR Report Key | 5880837 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-08-16 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-02-08 |
| Date Mfgr Received | 2016-04-25 |
| Date Added to Maude | 2016-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KAREN KRENIK, BSN |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517333091 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVILON NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2016-08-16 |
| Catalog Number | 3345 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-16 |