MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for OASIS 3600-100 manufactured by Atrium Medical Corporation.
[145974949]
Oasis dry suction water seal chest drain: lot #444010. When sterile package opened, missing cap over sterile tip of the connector line that connects to chest tube. Cap was not found in packaging or attached to device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8636026 |
| MDR Report Key | 8636026 |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-01 |
| Report Date | 2019-05-02 |
| Date Reported to FDA | 2019-05-02 |
| Date Reported to Mfgr | 2019-05-23 |
| Date Added to Maude | 2019-05-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OASIS |
| Generic Name | BOTTLE, COLLECTION, VACUUM |
| Product Code | KDQ |
| Date Received | 2019-05-23 |
| Model Number | 3600-100 |
| Lot Number | 444010 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | 40 CONTINENTAL BLVD. MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |