MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-10-11 for ARROW CDC-15703-P1A manufactured by Teleflex [arrow].
[17096088]
Pt had an internal jugular iv line placed in the operating room on (b)(6) 2011. During an interventional radiology procedure on (b)(6) 2011 a retained guidewire. 58 cm in length was identified within the inferior vena cava and right common iliac.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2359611 |
| MDR Report Key | 2359611 |
| Report Source | 99 |
| Date Received | 2011-10-11 |
| Date of Report | 2011-10-06 |
| Date of Event | 2011-09-28 |
| Date Facility Aware | 2011-09-28 |
| Report Date | 2011-10-06 |
| Date Added to Maude | 2011-12-07 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW |
| Generic Name | MULTILUMEN CVC KIT |
| Product Code | GBP |
| Date Received | 2011-10-11 |
| Model Number | CDC-15703-P1A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX [ARROW] |
| Manufacturer Address | P.O. BOX 12600 RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-10-11 |