MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-08 for CENTURION INTROFLEX ECVC1915 manufactured by Centurion Medical Products.
[92608872]
A critically sick patient in the micu needed an introducer inserted and the introducer broke during insertion rendering the catheter useless to clinicians.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038445-2017-00002 |
| MDR Report Key | 7010949 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-10-20 |
| Device Manufacturer Date | 2016-09-13 |
| Date Added to Maude | 2017-11-08 |
| 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 INTROFLEX |
| Generic Name | CENTRAL VENOUS CATHETER KIT |
| Product Code | OES |
| Date Received | 2017-11-08 |
| Returned To Mfg | 2017-10-12 |
| Model Number | ECVC1915 |
| Lot Number | 2016082950 |
| Device Expiration Date | 2018-03-31 |
| 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 | 2017-11-08 |