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.
[146095297]
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 further investigation can be done.
Patient Sequence No: 1, Text Type: N, H10
[146095298]
The event occured (b)(6) 2019 on a preterm infant (b)(6). The device was in until day 8 of baby's life. Liver injury following the use of the umbilical catheter. It is likely to be a liver haematoma but cannot exclude tpn/blood extravasation. The device has been removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2019-00028 |
| MDR Report Key | 8641350 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-24 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-01 |
| 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 | N |
| 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 |