MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-28 for UMBILICAL CATHETER 270.03200518FR, 060318FR OR 141117FR 270.03 manufactured by Vygon.
[146222172]
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. The batch review of the 3 supplied batches shows that the 3 batches are conforms to the specifications. There is no similar complaint reported on these 3 batches.
Patient Sequence No: 1, Text Type: N, H10
[146222173]
The event occured the (b)(6) 2019 on a baby. The device stays 4 days in the patient. The umbilical catheter snapped while being taken out. The distal end of the uac remained in the baby and had to be removed by surgical exploration. The baby is currently doing well and is stable. Both ends of the catheter are available. There are 3 probable batch numbers : 200518fr, 060318fr or 141117fr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2019-00030 |
| MDR Report Key | 8645583 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-28 |
| Date of Report | 2019-07-15 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-05-28 |
| 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 | 2019-05-28 |
| Model Number | 270.03200518FR, 060318FR OR 141117FR |
| Catalog Number | 270.03 |
| Lot Number | 200518FR, 060318FR OR 141117FR |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-28 |