MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-24 for UMBILICAL CATHETER, 1272.14 manufactured by Vygon.
[146095156]
As batch is unknown, no review can be done. All umbilical catheters are 100% tested for tightness and non-obstruction during the manufacturing process. The sample has not been retained. No investigation can be done.
Patient Sequence No: 1, Text Type: N, H10
[146095157]
The event occured (b)(6) 2019 on a preterm infant (b)(6). The device stays 3 days in the patient. The preterm infant had an extravasation of tpn fluid in liver and right pleural space leading to chest drain insertion. The device has been removed and chest drain inserted. No injury occured, patient gone home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2019-00027 |
| MDR Report Key | 8641347 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-05-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Manufacturer Street | 5 RUE ADELINE |
| Manufacturer City | ECOUEN, 95440 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CATHETER, |
| Generic Name | UMBILICAL CATHETER, |
| Product Code | FOS |
| Date Received | 2019-05-24 |
| Model Number | 1272.14 |
| Catalog Number | 1272.14 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON |
| Manufacturer Address | 5 RUE ADELINE ECOUEN, 95440 FR 95440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-24 |