MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-01 for NEO MAPCATH STYLET 0.8FR 60-2008 manufactured by Corpak Medsystems.
[17610103]
Event desc: during an over the cath exchange using the navigator instrument the nurse was having difficulty placing the line. The np had removed the wire and the line because she couldn't get it positioned appropriately. Upon removal she noticed a piece of the sensor wire was in the end of the catheter (approximately 10cm). It all came out with the line.
Patient Sequence No: 1, Text Type: D, B5
[17646104]
There was no report of injury. The actual sample has not been returned for evaluation. Samples from the same lot were tested at greater than 17n which is greater than any force expected in the clinical setting. Without a sample a definitive conclusion can not be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009124963-2013-00001 |
| MDR Report Key | 2957239 |
| Report Source | 05,06 |
| Date Received | 2013-02-01 |
| Date of Report | 2013-01-31 |
| Date of Event | 2013-01-04 |
| Date Mfgr Received | 2013-01-04 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2013-02-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1001 ASBURY DR |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8474033400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO MAPCATH STYLET 0.8FR |
| Generic Name | STYLET |
| Product Code | OMF |
| Date Received | 2013-02-01 |
| Model Number | 60-2008 |
| Lot Number | 4488 |
| Device Expiration Date | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORPAK MEDSYSTEMS |
| Manufacturer Address | 1001 ASBURY DR BUFFALO GROVE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-01 |