MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-21 for ENVIROSYSTEMS ETHYLENE OXIDE STERILANT manufactured by Steris Corporation.
[23697211]
The user facility observed the box was damaged and heavily wrapped with packaging tape. The user facility removed the canisters subject of the reported event and disposed them without incident. It is likely the carrier service damaged the package and its contents during shipment. The envirosystems ethylene oxide sterilant's material safety data sheet states in section 6: accidental release measures, "methods for cleaning up: spill should be handled by trained cleaning personnel properly equipped with respiratory and eye protection. Eliminate all ignition sources. Use water to dilute material. Contain any spills with dikes or absorbents to prevent migration and entry into sewers or streams. Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Comply with applicable local, national and international regulation. " steris employees are trained to reject or discard product which evidences signs of damage or deformation. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[23697212]
The user facility reported that they received a shipment of envirosystems ethylene oxide sterilant which arrived damaged. One canister leaked due to the reported damage. No report of injury and no medical treatment was sought or administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2015-00009 |
| MDR Report Key | 5021193 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-07-23 |
| Date Mfgr Received | 2015-07-23 |
| Date Added to Maude | 2015-08-21 |
| 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 | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION |
| Manufacturer Street | 7501 PAGE AVENUE |
| Manufacturer City | ST. LOUIS MO 63133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENVIROSYSTEMS ETHYLENE OXIDE STERILANT |
| Generic Name | STERILANT |
| Product Code | FLF |
| Date Received | 2015-08-21 |
| Lot Number | APR15028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 7501 PAGE AVENUE ST. LOUIS MO 63133 US 63133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-21 |