MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-09 for PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS 66-1991 manufactured by Smiths Medical Asd, Inc.
[144616177]
It was reported that during a bronchoscopy procedure, the blue top of the elbow separated from the elbow. When the separation occurred it caused the et tube to be pulled out of the patient. An urgent re-intubation of a new et tube was performed without any complications. The patient was reported to be doing well after this intervention was taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-02544 |
| MDR Report Key | 8597252 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-09 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2019-05-09 |
| 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 G1 | SMITHS MEDICAL, ASD INC. |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2019-05-09 |
| Model Number | 66-1991 |
| Catalog Number | 66-1991 |
| Lot Number | 3671388 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-09 |