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 2019-04-24 for SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT 11/810/080CZ manufactured by Smiths Medical Asd, Inc..
[142933305]
Information was received that while a patient was under local anesthesia, a smiths medical tracheal tube kit was used. When the balloon air bag cutting kit was implanted, the air bag was found to be leaking, and a new tracheal kit was immediately replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-02227 |
| MDR Report Key | 8545277 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-24 |
| 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 Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL CZECH REPUBLIC A.S. |
| Manufacturer Street | OLOMOUCK? 306 |
| Manufacturer City | HRANICE, MESTO 753 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 753 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT |
| Generic Name | TRACHEOSTOMY |
| Product Code | OGW |
| Date Received | 2019-04-24 |
| Catalog Number | 11/810/080CZ |
| Lot Number | 3615719 |
| 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 | 1. Required No Informationntervention | 2019-04-24 |