MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-24 for NUTRILINE TWINFLO 2FR 1252.230G manufactured by Vygon Usa.
[186731745]
The failed sample has been returned to vygon and will be evaluated as part of the complaint investigation. The results of this investigation are still pending and will be communicated to fda within 30 days of completion.
Patient Sequence No: 1, Text Type: N, H10
[186731746]
Catheter had been in dwell for 23 days infusing fentanyl, and was found to be leaking. The line was removed. No reported harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2020-00019 |
| MDR Report Key | 9873793 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4735414 |
| Manufacturer G1 | VYGON MFG |
| Manufacturer Street | 87 VENTURE DRIVE |
| Manufacturer City | DOVER, NH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUTRILINE TWINFLO 2FR |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | LJS |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-20 |
| Model Number | 1252.230G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON USA |
| Manufacturer Address | 2750 MORRIS ROAD LANSDALE, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |