MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-30 for CENTURION INTROFLEX ECVC6215 manufactured by Centurion Medical Products.
[146658372]
Filing for initial report, investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[146658373]
Sideport tubing disconnected from device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038445-2019-00003 |
| MDR Report Key | 8656028 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-08-19 |
| Date Added to Maude | 2019-05-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAREN KOWALCZYK |
| Manufacturer Street | 100 CENTURION WAY |
| Manufacturer City | WILLIAMSTON MI 48895 |
| Manufacturer Country | US |
| Manufacturer Postal | 48895 |
| Manufacturer Phone | 5175451122 |
| Manufacturer G1 | CENTURION MEDICAL PRODUCTS |
| Manufacturer Street | 3310 MAIN STREET |
| Manufacturer City | SALISBURY NC 28147 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28147 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION INTROFLEX |
| Generic Name | CARDIAC CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2019-05-30 |
| Model Number | ECVC6215 |
| Lot Number | 2018121850 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS |
| Manufacturer Address | 100 CENTURION WAY WILLIAMSTON MI 48895 US 48895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-30 |