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 2019-08-02 for SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBES 198-35L manufactured by Smiths Medical Asd, Inc..
[153213373]
Information was received that the cuff of a smiths medical endotracheal tube was noted to be leaking while in use. A tube change out was required as medical intervention. The device was reported to be functioning properly prior to use with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-03947 |
| MDR Report Key | 8858195 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-02 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-06-27 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2019-08-02 |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL, ASD INC. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | KENT, |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBES |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) |
| Product Code | CBI |
| Date Received | 2019-08-02 |
| Returned To Mfg | 2019-07-12 |
| Catalog Number | 198-35L |
| Lot Number | 3723286 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-02 |