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 2020-01-15 for PORTEX? UNIPERC? ADJUSTABLE TRACHEOSTOMY TUBE 100/897/080CZ manufactured by Smiths Medical Asd; Inc..
[175202986]
Information was received indicating that immediately following placement of a smiths medical portex? Uniperc? Adjustable tracheostomy tube, inability to ventilate the patient was observed. It was reported that the tube was leaking due to the non-waterproof balloon. Subsequently the trach tube was changed out with another model. The patient recovered with no further adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00254 |
| MDR Report Key | 9594312 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2018-11-22 |
| Date Added to Maude | 2020-01-15 |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL CZECH REPUBLIC A. S. |
| Manufacturer Street | OLOMOUCK? 306, HRANICE 1 |
| Manufacturer City | 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 | PORTEX? UNIPERC? ADJUSTABLE TRACHEOSTOMY TUBE |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
| Product Code | BTO |
| Date Received | 2020-01-15 |
| Catalog Number | 100/897/080CZ |
| Lot Number | 3721506 |
| 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 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |