MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-21 for NEIMAN SIL RB NASAL SPLT (2/PK) 140441 manufactured by Gyrus Acmi, Inc.
[100911999]
The device was returned to olympus for evaluation. The initial evaluation confirmed that the device original packaging was damaged and unsealed. The round circle seals of the box flaps were opened and slightly crushed on top. The sterile pouches were also not sealed on the bottom end; however, the splint silicones remained inside the package, and unused. The exact cause of the reported event cannot be determined at this time. The device will be sent to the original equipment manufacturer (oem) for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[100912000]
Olympus was informed that during preparation for use in the sterile field, the sterility of the device was found to be compromised, as the exterior packaging was found unsealed. The device was not used on a patient; therefore, no patient injury was reported. Additionally, the user facility reported that the device had been stored in its original box on a self prior to the reported incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00126 |
| MDR Report Key | 7287876 |
| Date Received | 2018-02-21 |
| Date of Report | 2018-04-12 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-02-21 |
| 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. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEIMAN SIL RB NASAL SPLT (2/PK) |
| Generic Name | NASAL SPLT |
| Product Code | LYA |
| Date Received | 2018-02-21 |
| Returned To Mfg | 2018-02-12 |
| Model Number | 140441 |
| Catalog Number | 140441 |
| Lot Number | MH666794 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |