FDA Adverse Event
Other
Summary report: N
PLEXOLONG
MDR report key: 1994415
·
Received February 2, 2011
Report
- Report Number
- 9611612-2011-00029
- Event Type
- Other
- Date Received
- February 2, 2011
- Date of Event
- January 21, 2011
- Report Date
- February 2, 2011
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- CAZ
- PMA / PMN Number
- K013041
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
AT THIS POINT, NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE MASTER RECORD AND THE RELEVANT RAW MATERIAL HISTORY FILES INDICATED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. AS SOON AS FURTHER INFO BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
(B)(4). EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO (B)(4) AUTHORITIES. USERS NARRATIVE: "CATHETER RUPTURE/ BREAKAGE/ CUT OFF, FRAGMENT REMAINS WITH PT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLEXOLONG | 868.5140 ANESTHESIA CONDUCTION KIT | CAZ | PAJUNK GMBH MEDIZINTECHNOLOGIE | 531156-31A | 894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |