MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-05 for FRANSEEN LUNG BIOPSY NEEDLE N/A DFBN-18-20.0 manufactured by Cook Inc.
[30509391]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[30509392]
Device was used as the center needle during a biopsy procedure. When the user was attempting to turn the hub portion, the needle broke off at the hub while still within the body of the patient. The device was removed with hemostats. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[45718518]
(b)(4). **** event evaluation **** a review of complaint history, drawings, manufacturing instructions and quality control was conducted during the investigation. The device was not returned to assist in the investigation. A review of the complaint history records found this to be an isolated report against the finished lot. There is no evidence to suggest the product was not manufactured to current specifications. Based on limited information, in addition to the suspect franseen lung biopsy needle not being returned, at this time we are unable to determine with certainty why the customer experienced difficulty. The appropriate internal personnel have been notified.
Patient Sequence No: 1, Text Type: N, H10
[45718519]
Device was used as the center needle during a biopsy procedure. When the user was attempting to turn the hub portion, the needle broke off at the hub while still within the body of the patient. The device was removed with hemostats. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00721 |
| MDR Report Key | 5204276 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-05 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-10-14 |
| Date Facility Aware | 2015-10-14 |
| Date Mfgr Received | 2015-10-16 |
| Device Manufacturer Date | 2015-09-14 |
| Date Added to Maude | 2015-11-05 |
| 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 | MRS. RITA HARDEN |
| 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 | 2015-11-05 |
| Model Number | N/A |
| Catalog Number | DFBN-18-20.0 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 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. Required No Informationntervention | 2015-11-05 |