MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-08-16 for CAVILON NO STING BARRIER FILM 3344 manufactured by 3m Health Care.
[52719432]
On 08/09/2016 date 3m management made the internal decision to file mdr report for this complaint. (b)(4). This report 2110898-2016-00081 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
[52719433]
Customer reported a cavilon no sting barrier film wipe was opened and ready for use in surgery prior to application of a wound vac device. An assisting surgeon had the cavilon no sting barrier film wipe attached to a kelly clamp and was about to apply the wipe to the skin area. At the same time, the primary surgeon ignited a cautery to remove some skin. Customer reported the wipe attached to the kelly clamp ignited. The assisting surgeon threw the clamp, with the wipe attached, off the surgical field where it extinguished. Customer reported there was no injury to patient or staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00081 |
| MDR Report Key | 5880845 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-08-16 |
| Date of Report | 2016-08-09 |
| Date of Event | 2014-07-28 |
| Date Mfgr Received | 2014-04-05 |
| 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 |
| 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 | 3344 |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| 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 |