MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-26 for ADMINISTRATION SET AMS-497-1 manufactured by Vygon Usa.
[128402379]
Although no device was returned for evaluation, the details of the malfunction will be evaluation as part of the complaint investigation. The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.
Patient Sequence No: 1, Text Type: N, H10
[128402380]
Iv set leaked. Epidural with perfusor pump. Drug was ripivocaine during patient's labor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2018-00084 |
| MDR Report Key | 8102372 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-26 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-11-26 |
| 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 | FREDA LACROIX |
| Manufacturer Street | 2750 MORRIS ROAD |
| Manufacturer City | LANSDALE PA 19446 |
| Manufacturer Country | US |
| Manufacturer Postal | 19446 |
| Manufacturer Phone | 8004735414 |
| Manufacturer G1 | VYGON MFG |
| Manufacturer Street | 87 VENTURE DRIVE |
| Manufacturer City | DOVER NH 03820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADMINISTRATION SET |
| Generic Name | ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2018-11-26 |
| Model Number | AMS-497-1 |
| Lot Number | 1804014D |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON USA |
| Manufacturer Address | 2750 MORRIS ROAD LANSDALE PA 19446 US 19446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-26 |