MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-21 for 3M? CAVILON? NO STING BARRIER FILM 3343E N/A manufactured by 3m Health Care Limited.
[180395207]
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.
Patient Sequence No: 1, Text Type: N, H10
[180395208]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00010 |
| MDR Report Key | 9740776 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-12-06 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-02-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? CAVILON? NO STING BARRIER FILM 3343E |
| Generic Name | 3M? CAVILON? NO STING BARRIER FILM 3343E |
| Product Code | KMF |
| Date Received | 2020-02-21 |
| Model Number | N/A |
| Catalog Number | 3343E |
| Lot Number | 2022-07 AA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE LIMITED |
| Manufacturer Address | DERBY ROAD LOUGHBOROUGH LEICESTERSHIRE, GB US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |