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.
[145935816]
Covering cap missing from sterile tip that connects to chest tube. Checked packaging and drainage box. Still could not find cap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8635959 |
| MDR Report Key | 8635959 |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-05-02 |
| Report Date | 2019-05-03 |
| Date Reported to FDA | 2019-05-03 |
| 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 |