FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 7FR X 2 0CM
MDR report key: 2193446
·
Received July 13, 2011
Report
- Report Number
- 3006425876-2011-00056
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 12, 2011
- Manufacturer
- ARROW INTERNATIONAL, INC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE DRESSING WAS REMOVED IN THE PT'S ROOM 2 WEEKS AFTER THE CATHETER WAS PLACED, THE DRESSING AT THE SITE (INTERNAL JUGULAR VEIN) WAS FOUND WET. SINCE THE CATHETER WAS GOING TO BE REMOVED WHEN THE DRESSING WAS FOUND WET, IT WAS REMOVED BUT NOT REPLACED. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC SET: 2-LUMEN 7FR X 2 0CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL, INC | ZF0123063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |