MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for OASIS SINGLE DRAIN 3600-100 manufactured by Atrium Medical Corporation.
[186841063]
A follow up report will be submitted upon the completion of the investigation into this event.
Patient Sequence No: 1, Text Type: N, H10
[186841064]
Hospital reported they had a device leak on set-up. When investigating they observed a crack on the drain body.
Patient Sequence No: 1, Text Type: D, B5
[188145772]
A review of the returned drain confirmed the presence of a large crack in the lower front panels of the drain. A crack of the drain of this nature could only be caused by a very blunt force applied such as a drop of the drain or shipping and handling damage. The drains during the process of manufacturing undergo a full system pressure test to ensure the integrity of the drain. A crack of this nature would have easily been detected and rejected by the automated system. This crack is also large enough that the manufacturing operator would have been able to visually see the crack as well. A review of the device history records indicates that the lot of chest drains passed all quality and performance requirements prior to being released. The instruction for use state "do not use if device or package is damaged". Summary/conclusion - based on the results of the investigation the most probable root cause of the cracked oasis chest drains is that the product was damaged while in transit. A large crack would have been noticed during the multiple manufacturing process steps in manufacturing including the 100% product leak test.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011175548-2020-00316 |
| MDR Report Key | 9744054 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-12-02 |
| Date Added to Maude | 2020-02-24 |
| 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 Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OASIS SINGLE DRAIN |
| Generic Name | APPARATUS, AUTOTRANSFUSION |
| Product Code | CAC |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 3600-100 |
| Catalog Number | 3600-100 |
| Lot Number | 452818 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-24 |