MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-02-27 for BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT 100/811/080CZ manufactured by Smiths Medical Asd, Inc..
[137301326]
Information was received that a smiths medical tracheostomy had a cannula crack, requiring replacement. The incident was reported as being resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-01048 |
| MDR Report Key | 8375252 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2019-02-27 |
| 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 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT |
| Generic Name | TRACHEOBRONCHIAL SUCTION CATHETER KIT |
| Product Code | OFR |
| Date Received | 2019-02-27 |
| Catalog Number | 100/811/080CZ |
| Lot Number | 3597096 |
| 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 | 2019-02-27 |