MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-25 for ARMSTRONG V TYPE GROMMET 1.14MM I.D. FLPL PC (60/PK) 70140397 manufactured by Osta.
[51070598]
The device was returned to olympus for evaluation. A visual and microscopic inspection upon the received condition of the device noted two devices inside the slots of the blue container; also a dried yellow foreign material in the container was noted. The device was received opened without the original sterilized packaging. The root cause of the reported event could not be determined. The device will be sent to the oem for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[51070599]
It was reported that upon receipt of the device at user facility a foreign object was observed in the packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00607 |
| MDR Report Key | 5820397 |
| Date Received | 2016-07-25 |
| Date of Report | 2016-07-25 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-07-07 |
| Date Added to Maude | 2016-07-25 |
| 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 | MR DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARMSTRONG V TYPE GROMMET 1.14MM I.D. FLPL PC (60/PK) |
| Generic Name | PC COATED FLUOROPLASTIC VENT TUBES |
| Product Code | ETD |
| Date Received | 2016-07-25 |
| Returned To Mfg | 2016-07-13 |
| Model Number | 70140397 |
| Catalog Number | 70140397 |
| Lot Number | SD947688 |
| ID Number | UDI |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-25 |