MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-30 for VANTEX CVC WITH OLIGON MATERIAL ECVC3475 manufactured by Centurion Medical Products Corp..
[46570601]
In preparation for catheter insertion, staff were attempting to flush the triple lumens of a central venous catheter and were unable to do so. After 5 separate catheter kits were tried and all were blocked to one degree or another, staff examined the end of the catheter and identified two teal cylindrical pieces of plastic approximately 1/4" long, one with a small piece of clear plastic attached and the other with the clear plastic piece separated from the teal piece. These teal pieces are the same color as the hub for the triple lumens. Both the medial and proximal lumens were blocked to some degree. These small pieces presented a serious patient safety issue and these catheters pulled from use and marked do not use. The next day, the decision was made to pull all of the manufacturer's catheters as a precaution and supply chain ordered replacement arrow catheters to use in the meantime.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062582 |
| MDR Report Key | 5694249 |
| Date Received | 2016-05-30 |
| Date of Report | 2016-05-30 |
| Date of Event | 2016-05-24 |
| Date Added to Maude | 2016-06-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | VANTEX CVC WITH OLIGON MATERIAL |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | FOZ |
| Date Received | 2016-05-30 |
| Model Number | ECVC3475 |
| Lot Number | 2016032250 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORP. |
| Manufacturer Address | WILLIAMSTON MI 48895 US 48895 |
| Brand Name | VANTEX CVC WITH OLIGON MATERIAL |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | LRS |
| Date Received | 2016-05-30 |
| Model Number | ECVC3475 |
| Lot Number | 2016032250 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORP. |
| Manufacturer Address | WILLIAMSTON MI 48895 US 48895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-30 |