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 2018-12-06 for MINI-TRACH II SELDINGER 4.0MM CRICOTHYROIDOTOMY KIT 100/461/000 manufactured by Smiths Medical Asd, Inc..
[129583845]
Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129583846]
Information was received that a smiths medical tracheostomy tube was bent, making it difficult to secure the airway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-08564 |
| MDR Report Key | 8140005 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-12-06 |
| 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, ASD INC. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | KENT, HYTHE |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI-TRACH II SELDINGER 4.0MM CRICOTHYROIDOTOMY KIT |
| Generic Name | CRICOTHYROTOMY KIT |
| Product Code | OGP |
| Date Received | 2018-12-06 |
| Returned To Mfg | 2018-11-09 |
| Catalog Number | 100/461/000 |
| Lot Number | 3053047 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-12-06 |