MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-27 for MULTI-MED KIT * manufactured by Centurion Medical Products.
[2725039]
Introducer needle in centurion multi-med central venous catheter (4 lumen) had no connectivity to syringe. New kit was used instead.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2619318 |
MDR Report Key | 2619318 |
Date Received | 2012-04-27 |
Date of Report | 2012-04-27 |
Report Date | 2012-04-27 |
Date Reported to FDA | 2012-04-27 |
Date Added to Maude | 2012-06-18 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MULTI-MED KIT |
Generic Name | CARDIAC CATHETERIZATION KIT |
Product Code | OES |
Date Received | 2012-04-27 |
Model Number | * |
Catalog Number | * |
Lot Number | 2011050950 |
ID Number | * |
Device Availability | N |
Device Age | 1 DY |
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 | 2012-04-27 |