N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
MAUDE MDR 6202475
- MDR report key
- 6202475
- Report number
- 1820334-2016-01557
- Event key
- 0
- Event type
- 3
- Date received
- 2016-12-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- 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 | 2016-12-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THE PATIENT HAS HAD THREE TOTAL PARENTERAL NUTRITION CATHETERS REPLACED FOR THE FOLLOWING REASONS: ? THE BLUE LUMEN HAS BLOOD BACK FLOW ISSUE- MEDWATCH# 1820334-2016-01557 (THIS REPORT) ? REPLACED DUE TO BREAK PRIOR TO BMT- MEDWATCH# 1820334-2016-01592. ? OCCLUSION THE AFFECTED BLUE LUMEN WHERE PATENCY COULD NOT BE RESTORED WITH ALTEPLASE MEDWATCH# 1820334-2016-01600. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
N
Patient 1
INVESTIGATION ? EVALUATION: A REVIEW OF THE QUALITY CONTROL AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.