MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-09 for ESIVENT 20725 manufactured by Smiths Medical Asd, Inc..
[182419218]
Information was received that during the use of a smiths medical easivent nebulizer, the round mouthpiece broke off entirely from the base of the valved holding chamber that patient placed to her mouth to inhale the medication. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00954 |
| MDR Report Key | 9685074 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-09 |
| Date of Report | 2020-02-08 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-01-17 |
| Date Added to Maude | 2020-02-09 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA |
| Manufacturer Street | 201 WEST QUEEN STREET |
| Manufacturer City | SOUTHINGTON CT 06489 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06489 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESIVENT |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) PRODUCT CODE: CAF |
| Product Code | CAF |
| Date Received | 2020-02-09 |
| Catalog Number | 20725 |
| Lot Number | 3736113 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-09 |