MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-27 for UMBILICAL CATHETER 270.04 manufactured by Vygon.
[181402413]
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. No non-conformities of the batch history records detected. The products are in conformity with the specifications. The device is compliant to iso norm 10555-1. The tensile strength is higher than 10n which is the norm minimum value. There is no other complaint on this batch.
Patient Sequence No: 1, Text Type: N, H10
[181402414]
An umbilical catheter was introduced. Then x-ray was done. The catheter was broken during correction of the position of this catheter. Urgent consultation of a pediatric specialist. Removal of the entire fragment of the umbilical catheter. The patient feels good, his condition is stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2020-00010 |
| MDR Report Key | 9762534 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-27 |
| 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 | UMBILICAL CATHETER |
| Generic Name | UMBILICAL CATHETER |
| Product Code | FOS |
| Date Received | 2020-02-27 |
| Model Number | 270.04 |
| Catalog Number | 270.04 |
| Lot Number | 070119FQ |
| 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. Required No Informationntervention | 2020-02-27 |