MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-30 for SAFE-T-CENTESIS KIT 8FR X 16CM PIG1280K manufactured by Carefusion, Inc.
Report Number | 9680904-2019-00017 |
MDR Report Key | 8842650 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-07-30 |
Date of Report | 2019-10-11 |
Date of Event | 2019-07-18 |
Date Mfgr Received | 2019-07-19 |
Date Added to Maude | 2019-07-30 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | BDX ANNA WEHRHEIM |
Manufacturer Street | 75 N. FAIRVIEW DRIVE |
Manufacturer City | VERNON HILLS IL 60061 |
Manufacturer Country | US |
Manufacturer Postal | 60061 |
Manufacturer Phone | 8015652341 |
Manufacturer G1 | CAREFUSION, INC |
Manufacturer Street | ZONA FRANCA LAS AMERICAS |
Manufacturer City | SANTO DOMINGO |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SAFE-T-CENTESIS KIT 8FR X 16CM |
Generic Name | THORACENTESIS TRAY |
Product Code | PXI |
Date Received | 2019-07-30 |
Catalog Number | PIG1280K |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CAREFUSION, INC |
Manufacturer Address | ZONA FRANCA LAS AMERICAS SANTO DOMINGO |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-07-30 |