FDA Adverse Event
Other
Summary report: N
UP NANOLINE
MDR report key: 1303784
·
Received January 30, 2009
Report
- Report Number
- 9611612-2009-00014
- Event Type
- Other
- Date Received
- January 30, 2009
- Date of Event
- January 16, 2008
- Report Date
- January 30, 2009
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- PMA / PMN Number
- K053283
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT/USER/THIRD PERSON WAS HARMED. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE AFFECTED DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. IF NO FURTHER INFORMATION IS AVAILABLE ALLOWING PAJUNK TO DETERMINE THE ROOT CAUSE THE FILE IS CONSIDERED AS CLOSED.
Description of Event or Problem · 1
AE TOOK PLACE IN (B)(6). UP-NANOLINE NEEDLES SHOWED LEAKAGE WHILE INJECTING. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UP NANOLINE | NEEDLE, ANESTHESIA | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 001156-74 | 789= 10/2008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |