MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-12 for CENTURION MULTI-MED ECVC2240 manufactured by Centurion Medical Products.
[85806307]
While placing a cvc in the right subclavian, the guidewire came apart. Doctor tried to remove the guidewire out of soft tissue, this was unsuccessful. Patient was then prepped and an incision was made to remove the wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038445-2017-00001 |
| MDR Report Key | 6858797 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-12 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-08-08 |
| Date Mfgr Received | 2017-08-18 |
| Device Manufacturer Date | 2017-01-19 |
| Date Added to Maude | 2017-09-12 |
| 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 | MR. MATTHEW PRICE |
| Manufacturer Street | 100 CENTURION WAY |
| Manufacturer City | WILLIAMSTON MI 48895 |
| Manufacturer Country | US |
| Manufacturer Postal | 48895 |
| Manufacturer Phone | 5175451135 |
| Manufacturer G1 | CENTURION MEDICAL PRODUCTS |
| Manufacturer Street | 3310 SOUTH MAIN ST. |
| 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 MULTI-MED |
| Generic Name | CENTRAL VENOUS CATHETER KIT |
| Product Code | OES |
| Date Received | 2017-09-12 |
| Returned To Mfg | 2017-08-21 |
| Model Number | ECVC2240 |
| Lot Number | 2017010950 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS |
| Manufacturer Address | 3310 S MAIN ST. SALISBURY NC 28147 US 28147 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-12 |