MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for CENTURION QUAD KIT CUSTOM CENTRAL LINE ECVC6770 manufactured by Centurion Medical Products Corporation.
[183099654]
The guide wire had difficulty advancing during line placement. When the wire was removed, the wire noted to be defective and had uncoiled. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093595 |
| MDR Report Key | 9805007 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-05 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION QUAD KIT CUSTOM CENTRAL LINE |
| Generic Name | CARDIAC CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2020-03-06 |
| Model Number | ECVC6770 |
| Catalog Number | ECVC6770 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |