FDA Adverse Event
Other
Summary report: N
SPROTTE STANDARD 25G X 90 MM INTRODUCER
MDR report key: 1951139
·
Received December 22, 2010
Report
- Report Number
- 9611612-2010-00022
- Event Type
- Other
- Date Received
- December 22, 2010
- Date of Event
- November 25, 2010
- Report Date
- December 22, 2010
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- CAZ
- PMA / PMN Number
- K911221
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MAY BE RETURNED TO MFR FOR EVAL. AT THIS POINT, NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTIVE OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE 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 INFO BECOMES AVAILABLE AND IN CASE NO CORRECTIVE/PREVENTIVE ACTION IS INDICATED, PAJUNK CONSIDERS THIS FILE AS CLOSED.
Description of Event or Problem · 1
(B)(4). EVENT TOOK PLACE IN (B)(6). USER'S NARRATIVE: UPON INJECTING AGENT INTO NEEDLE, FLUID WAS SEEN AT THE HUB PART OF THE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPROTTE STANDARD 25G X 90 MM INTRODUCER | 868.5150 ANESTHESIA CONDUCTION NEEDLE | CAZ | PAJUNK GMBH MEDIZINTECHNOLOGIE | 02115129AB BULK | 02180769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |