MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS 66-1991 manufactured by Smiths Medical Asd; Inc..
[119498872]
Information was received indicating that the bronchoscope was unable to be passed through a smiths medical swivel connector aerosol adapter causing the scope sheath to stretch. It was noted that the scope was then needing to be repaired. The seal was reported to be too tight and that the procedure was unable to be performed on the critical patient. There were reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-03579 |
| MDR Report Key | 7844336 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2018-01-18 |
| Date Added to Maude | 2018-09-04 |
| 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 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA |
| 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 | 0 |
| Brand Name | PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2018-09-04 |
| Catalog Number | 66-1991 |
| Lot Number | 3572937 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-04 |