MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-24 for CVC KIT: 3-LUMEN 7 FR X 20 CM AK-15703 manufactured by Arrow International, Inc..
[3454612]
It was reported the pt underwent a left internal jugular approach. Upon insertion, the spring wire guide 'frayed" during the procedure and a 2. 5cm piece of the wire was left in soft tissue of the left neck. The pt was taken to the operating room. Using fluoroscopy, a cut down was performed to remove the portion of wire. Using a different insertion site another multi lumen catheter was placed for temporary infusion use. Mfr 1036844-2006-00079.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3131168 |
| MDR Report Key | 3131168 |
| Date Received | 2006-10-24 |
| Date of Report | 2006-10-23 |
| Date of Event | 2006-09-02 |
| Date Added to Maude | 2013-05-29 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVC KIT: 3-LUMEN 7 FR X 20 CM |
| Generic Name | ADULT MULTI-LUMEN CATHETER PRODUCTS |
| Product Code | GBP |
| Date Received | 2006-10-24 |
| Model Number | NA |
| Catalog Number | AK-15703 |
| Lot Number | RF0609027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-24 |