FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 2-LUMEN 7FR X 2 0CM
MDR report key: 2850155
·
Received November 21, 2012
Report
- Report Number
- 1036844-2012-00336
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 20, 2012
- Manufacturer
- ARROW INTL., 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 INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE CATH LAB, EIGHT HOURS AFTER THE CATHETER WAS PLACED IN THE PT'S RIGHT INTERNAL JUGULAR VEIN, APPROX 8 CM OF THE CATHETER HAD MIGRATED FROM THE INSERTION SITE. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT. IT WAS NOTED THAT THE USER USED THE CATHETER CLAMP, BUT NOT THE BLUE CLAMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC KIT: 2-LUMEN 7FR X 2 0CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTL., INC. | RF2010707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |