MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for SECURACATH 7F 400120 manufactured by Interrad Medical, Inc.
[141752985]
After inserting a double lumen central venous line, md applied 7 fr secure-a-cath and noted that the lines were occluded following application of the device. Device removed.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 8508593 |
MDR Report Key | 8508593 |
Date Received | 2019-04-12 |
Date of Report | 2019-03-28 |
Date of Event | 2019-03-28 |
Report Date | 2019-03-28 |
Date Reported to FDA | 2019-03-28 |
Date Reported to Mfgr | 2019-04-12 |
Date Added to Maude | 2019-04-12 |
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 | 3 |
Reporter Occupation | RISK MANAGER |
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 | 3 |
Brand Name | SECURACATH |
Generic Name | IMPLANTED SUBCUTANEOUS SECUREMENT CATHETER |
Product Code | OKC |
Date Received | 2019-04-12 |
Model Number | 7F |
Catalog Number | 400120 |
Lot Number | A1850 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 1 DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTERRAD MEDICAL, INC |
Manufacturer Address | 181 CHESHIRE LANE SUITE 100 PLYMOUTH MN 55441 US 55441 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-04-12 |