N
Patient 1
(B)(4). EVENT IS STILL UNDER INVESTIGATION.
MAUDE MDR 5204276
- MDR report key
- 5204276
- Report number
- 1820334-2015-00721
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-10-14
- Date received
- 2015-11-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. RITA HARDEN
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-05 | 0 | 1. R |
Event Narratives#
D
Patient 1
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.
N
Patient 1
(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.
D
Patient 1
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.