FDA Adverse Event
Malfunction
Summary report: N
PSI KIT: 8.5 FR
MDR report key: 1737793
·
Received June 11, 2010
Report
- Report Number
- 3006425876-2010-00044
- Event Type
- Malfunction
- Date Received
- June 11, 2010
- Date of Event
- March 28, 2010
- Report Date
- June 9, 2010
- Manufacturer
- ARROW INTERNATIONAL
- Product Code
- KGZ
- PMA / PMN Number
- K781846
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT BLOOD WAS LEAKING FROM THE DEVICE THROUGH THE HEMOSTASIS VALVE DURING INSERTION OF THE EDWARDS LIFESCIENCE SWAN GANZ 7FR CATHETER. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO REPORTED CONSEQUENCE FOR THE PATIENT. THERE WAS NO REPORTED DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PSI KIT: 8.5 FR | CRITICAL CARE PSI PRODUCTS | KGZ | ARROW INTERNATIONAL | ZF9111269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | EDWARDS LIFESCIENCE SWAN GANZ CATHETER |