MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-01 for 4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY VYML4S1001 manufactured by Vygon Usa.
| Report Number | 2245270-2019-00061 |
| MDR Report Key | 9139822 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-01 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-09-22 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-10-01 |
| 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 | CLAIRE PADDOCK |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY |
| Generic Name | MIDLINE CATHETER |
| Product Code | PND |
| Date Received | 2019-10-01 |
| Model Number | VYML4S1001 |
| Catalog Number | VYML4S1001 |
| Lot Number | 19G020D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-10-01 |