MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-05 for SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE 198-32L manufactured by Smiths Medical Asd, Inc..
[169308879]
Information was received that while a smiths medical endotracheal tube was in use with a patient, the device was noted to be leaking air from the bronchial cuff. The cuff was noted to be damaged. No patient injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-07012 |
| MDR Report Key | 9418746 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-05 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-05-22 |
| Date Added to Maude | 2019-12-05 |
| 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 G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) |
| Product Code | CBI |
| Date Received | 2019-12-05 |
| Returned To Mfg | 2019-11-29 |
| Model Number | 198-32L |
| Catalog Number | 198-32L |
| Lot Number | 3792424 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-05 |