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 |