MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-02-08 for FRANSEEN LUNG BIOPSY NEEDLE DSFBN-20-10.0 manufactured by Cook, Inc..
[3330403]
A (b)(6) male with a mass in his right lung underwent a fine needle biopsy of the right lung on (b)(6) 2013. The customer had difficulty in penetrating the skin and lesion. It felt like the end might have been bent. Tried a second needle which passed without difficulty. With the third pass, had the same difficulty again. Could not pass through the skin and needed force. The sample was not easily obtained. The pt developed a pneumothorax which required regular chest x-ray and medical examination in the emergency department. The pneumothorax was ongoing with slight pain and no obvious shortness of breath.
Patient Sequence No: 1, Text Type: D, B5
[10539414]
(b)(4). No product was returned to assist in this investigation. The bevel is 100% inspected in quality control to verify bevel is sharp, clean and free of burrs. All devices are examined to ensure that the correct bevels are on the stylets and proper alignment between cannula and stylet. Without the complaint device, a thorough investigation is not possible. Pt anatomy and density of lesion may affect case of device use. The root cause is inconclusive. We will continue to monitor for similar complaints. Per quality engineering risk analysis, there is insufficient risk to warrant risk reduction activities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00066 |
| MDR Report Key | 2958238 |
| Report Source | 01,08 |
| Date Received | 2013-02-08 |
| Date of Report | 2013-01-10 |
| Date of Event | 2013-01-09 |
| Date Facility Aware | 2013-01-09 |
| Report Date | 2013-01-10 |
| Date Mfgr Received | 2013-01-17 |
| Device Manufacturer Date | 2012-10-23 |
| Date Added to Maude | 2013-02-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRANSEEN LUNG BIOPSY NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2013-02-08 |
| Model Number | NA |
| Catalog Number | DSFBN-20-10.0 |
| Lot Number | 3757413 |
| ID Number | NA |
| Device Expiration Date | 2017-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-08 |