FDA Adverse Event
Malfunction
Summary report: N
IAB: 8 FR - 30 CC
MDR report key: 1230374
·
Received November 7, 2008
Report
- Report Number
- 1219856-2008-00515
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 10, 2008
- Report Date
- November 7, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K000729
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE INTRA-AORTIC BALLOON (IAB) WE INSERTED, THE STAFF NOTICED "SOME AIR CONTAINED FROM THE PART BETWEEN THE STOPCOCK AND TUBE OF THE EXTENSION TUBE." AS A RESULT, THE EXTENSION TUBING WAS EXCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 8 FR - 30 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | MF7097189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |