MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-08-10 for NAVILYST MEDICAL UNK manufactured by Navilyst Medical.
[2928233]
As reported by navilyst medical's distributor in (b)(6), during prep for a procedure, foreign matter was observed inside the female fitting of a 72" pressure monitoring line. The device was replaced and was not used on a patient. The reported device has been returned to navilyst medical for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[10034258]
Although the reported device has been returned to navilyst medical, the evaluation has not yet been completed. Upon completion of the investigation, a supplemental medwatch will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317056-2012-00029 |
| MDR Report Key | 2708860 |
| Report Source | 01,08 |
| Date Received | 2012-08-10 |
| Date of Report | 2012-07-13 |
| Date of Event | 2012-07-10 |
| Date Mfgr Received | 2012-07-13 |
| Date Added to Maude | 2012-11-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL DUERR |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424571 |
| Manufacturer G1 | NAVILYST MEDICAL |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVILYST MEDICAL |
| Generic Name | PRESSURE MONITORING LINE |
| Product Code | DRI |
| Date Received | 2012-08-10 |
| Returned To Mfg | 2012-07-30 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL |
| Manufacturer Address | GLENS FALLS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-10 |