MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-19 for PORTEX? BLUE LINE ULTRA? TRACHEOSTOMY TUBE 100/810/080CZ manufactured by Smiths Medical Asd; Inc..
[184247136]
Information was received indicating that a cannula to a smiths medical portex? Blue line ultra? Tracheostomy tube was noted to be occluded. It was reported that the handle of the trach tube was "fragile" and difficult for the patient to remove for secretion removal. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02166 |
| MDR Report Key | 9857790 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-10-08 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-01-25 |
| Date Added to Maude | 2020-03-19 |
| 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 N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL CZECH REPUBLIC A. S. |
| Manufacturer Street | OLOMOUCK 306 |
| Manufacturer City | HRANICE 1-MESTO, |
| Manufacturer Country | EZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? BLUE LINE ULTRA? TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-19 |
| Catalog Number | 100/810/080CZ |
| Lot Number | 3721470 |
| Operator | HEALTH PROFESSIONAL |
| 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 N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |