MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-18 for UMBILICA CATHETER 1272.04 manufactured by Vygon.
[179783718]
The failed sample will be returned to vygon for device evaluation as part of the complaint investigation. The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion.
Patient Sequence No: 1, Text Type: N, H10
[179783719]
(b)(6) week gestation infant born on (b)(6). Umbilical venous catheter inserted on the day of birth. On (b)(6) referred from hospital to (b)(6) with an acute abdomen. Tpn extravasation diagnosed at (b)(6) secondary to liver and abdominal extravasation of tpn from umbilical venous catheter. Drained soon after admission to (b)(6) with surgical peritoneal drain. Umbilical catheter removed. This catheter stays 5 days in situ. Baby subsequently went on to develop intractable renal failure and necrotising enterocolitis with perforation needing laparotomy. Palliative care commenced and intensive care withdrawn on the (b)(6). Baby died on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
[187468506]
We have received the involved umbilical catheter. During the investigation, the returned device functioned normally, with no signs of leakage identified when flushing either lumen of the device. Unfortunately, we are unaware as to how the location of the device was confirmed after placement. The instructions for use (ifu) provided with the device advise: "control of positioning: always check the location of the catheter by radiography. For umbilical arterial catheterization, the catheter can be sited either in the high position between thoracic vertebrae t6 and t9 or the low position at l3 to l5 level though the higher position is associated with lower complication rates. For umbilical venous catheterization, the catheter tip should be placed beyond the ductus venosus in the central venous system (inferior vena cava). " the returned catheter is conform, there is no defect. On evaluation of our historical datas since 2017, we can confirm that we have not received any additional reports of a similar nature for this product. The root cause of this adverse event is not linked to the quality of our device.
Patient Sequence No: 1, Text Type: N, H10
[187468507]
(b)(6) gestation infant born on (b)(6). Umbilical venous catheter inserted on the day of birth. On (b)(6) referred from hospital to (b)(6) with an acute abdomen. Tpn extravasation diagnosed at (b)(6) to liver and abdominal extravasation of tpn from umbilical venous catheter. Drained soon after admission to (b)(6) with surgical peritoneal drain. Umbilical catheter removed. This catheter stays 5 days in situ. Baby subsequently went on to develop intractable renal failure and necrotising enterocolitis with perforation needing laparotomy. Palliative care commenced and intensive care withdrawn on the (b)(6). Baby died on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2020-00008 |
| MDR Report Key | 9720395 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-12 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-18 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4735414237 |
| 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 | UMBILICA CATHETER |
| Generic Name | UMBILICAL CATHETER |
| Product Code | FOS |
| Date Received | 2020-02-18 |
| Model Number | 1272.04 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| 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. Death | 2020-02-18 |