MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-28 for TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) YES JP-03411; US-87519; B/L ULTRA SUCTIONAID 8.0MM 10/CA 100/800/060 manufactured by Smiths Medical Asd,inc.
[185482216]
Information received a smith medical tracheostomy
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02355 |
| MDR Report Key | 9895002 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2020-03-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. |
| Manufacturer Street | AVE CALIDAD NO. 4, PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA, B.C. 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) YES JP-03411; US-87519; |
| Generic Name | TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-28 |
| Returned To Mfg | 2020-03-06 |
| Model Number | B/L ULTRA SUCTIONAID 8.0MM 10/CA |
| Catalog Number | 100/800/060 |
| Lot Number | 3702846 |
| 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 LANE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-28 |