MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-05 for NEO MAPCATH STYLET 30-2-8 60-2008 manufactured by Corpak Medsystem.
[3105198]
0. 8 fr corpak sensor stylet (lot #4488)was placed in 2fr bard per-q-cath picc line (lot# rewc0364 exp. 2014-03) picc place in patient and was having malposition to jugular vein. Attempted proper position stylet was removed and noted to have broken off in the patient. Retrieved 4 days later. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2890503 |
| MDR Report Key | 2890503 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-12-05 |
| Date of Event | 2012-07-20 |
| Report Date | 2012-12-05 |
| Date Reported to FDA | 2012-12-05 |
| Date Added to Maude | 2012-12-31 |
| 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 | NEO MAPCATH STYLET |
| Generic Name | PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER AC |
| Product Code | FOK |
| Date Received | 2012-12-05 |
| Model Number | 30-2-8 |
| Catalog Number | 60-2008 |
| Lot Number | 4488 |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORPAK MEDSYSTEM |
| Manufacturer Address | 1001 ASBURY DR BUFFALO GROVE IL 60089 US 60089 |
| Brand Name | 2FR BARD PER-Q-CATH PICC LINE |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 |
| Product Code | FOZ |
| Date Received | 2012-12-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | REWC0364 |
| ID Number | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Manufacturer Address | 605 NORTH 5600 WEST SALT LAKE CITY UT 84116373 US 84116 3738 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-05 |