MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-22 for NEO MAPCATH SENSOR STYLET 0.8 FR 60-2008 manufactured by Corpak Medsystems.
[3408697]
Wire stylet used in advancing picc line broke in two pieces while inside the pt becoming intravascular foreign bodies. Each piece required surgical intervention for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3035957 |
| MDR Report Key | 3035957 |
| Date Received | 2013-02-22 |
| Date of Report | 2013-02-21 |
| Date of Event | 2013-02-05 |
| Date Facility Aware | 2013-02-05 |
| Report Date | 2013-02-22 |
| Date Reported to FDA | 2013-02-22 |
| Date Reported to Mfgr | 2013-02-22 |
| Date Added to Maude | 2013-04-05 |
| 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 |
| 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 SENSOR STYLET |
| Generic Name | NAVIGATOR WIRE |
| Product Code | OMF |
| Date Received | 2013-02-22 |
| Model Number | 0.8 FR |
| Catalog Number | 60-2008 |
| Lot Number | 4488 |
| Device Expiration Date | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORPAK MEDSYSTEMS |
| Manufacturer Address | WHEELING IL 60090 US 60090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2013-02-22 |