MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-29 for PORTEX ADULT TTS ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY TUBE 67HA70 manufactured by Smiths Medical Asd, Inc..
[185481592]
Information was received that a patient's portex adult tts adjustable neck flange hyperflex tracheostomy tube leaked. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02398 |
| MDR Report Key | 9895013 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-28 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-29 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 5700 WEST 23RD AVENUE |
| Manufacturer City | GARY, IN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX ADULT TTS ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF, PRODUCT CODE: JOH |
| Product Code | JOH |
| Date Received | 2020-03-29 |
| Returned To Mfg | 2020-03-25 |
| Catalog Number | 67HA70 |
| Operator | HEALTH PROFESSIONAL |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-29 |