FDA Adverse Event
Malfunction
Summary report: N
Z-MED II CATHETER
MDR report key: 2043148
·
Received February 24, 2011
Report
- Report Number
- 9618000-2011-00003
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 22, 2011
- Manufacturer
- NUMED CANADA, INC.
- Product Code
- DQY
- PMA / PMN Number
- K030589
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A COMPARATIVE CATHETER WAS PULLED FROM STOCK AND TESTED FOR RBP. IT WAS TAKEN TO 7 ATM WHICH IS THE RBP FOR THIS SIZE OF BALLOON. THE BALLOON DID NOT BURST. IT WAS THEN TAKEN TO BURST WHICH WAS 12 ATM AND WAS A CLEAN AND LONGITUDINAL BURST. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED, HOWEVER, IT WAS TAKEN ABOVE THE RBP OF 7 ATM. HOSPITAL STATED THAT IT BURST AT 8.5 ATM.
Description of Event or Problem · 1
BALLOON BURST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Z-MED II CATHETER | PTV CATHETER | DQY | NUMED CANADA, INC. | 305 | JZ-7575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |