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 2020-03-16 for PORTEX UNIPERC INNER CANNULAE 100/899/070CZ manufactured by Smiths Medical Asd, Inc..
[183473316]
Foreign report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183473317]
Information was received that the blue locksystem on a smiths medical regarding a portex uniperc inner cannula did not work. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02018 |
| MDR Report Key | 9833561 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-15 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-08-28 |
| Date Added to Maude | 2020-03-16 |
| 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 CZECH REPUBLIC A. S. |
| Manufacturer Street | OLOMOUCK 306, HRANICE 1 - MESTO |
| Manufacturer City | HRANICE, 75301 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 75301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX UNIPERC INNER CANNULAE |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO |
| Product Code | BTO |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 100/899/070CZ |
| Catalog Number | 100/899/070CZ |
| Lot Number | 3827426 |
| 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 | 2020-03-16 |