FDA Adverse Event
Malfunction
Summary report: N
PSI KIT: 8.5 FR
MDR report key: 2483315
·
Received February 20, 2012
Report
- Report Number
- 2242445-2012-00033
- Event Type
- Malfunction
- Date Received
- February 20, 2012
- Date of Event
- February 21, 2012
- Report Date
- February 29, 2012
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- KGZ
- PMA / PMN Number
- K781846
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
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 AS SOON AS THE MEDICAL SOLUTION WAS INJECTED IN THE OPERATING ROOM, A LEAK FROM THE HANDLE OF THE STOPCOCK WAS FOUND. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PSI KIT: 8.5 FR | CRITICAL CARE PSI PRODUCTS | KGZ | ARROW INTERNATIONAL INC | MF1050451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |