FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 2-LUMEN 12 FR X 6IN (16 CM)
MDR report key: 2080087
·
Received April 7, 2011
Report
- Report Number
- 1036844-2011-00115
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 15, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- LFJ
- PMA / PMN Number
- K895417
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE OF THE FELLOWS ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO REMOVE THE SPRING WIRE GUIDE (SWG) FROM THE CATHETER DURING INSERTION INTO THE PT'S RIGHT FEMORAL VEIN. AS SHE APPLIED FORCE TO REMOVE THE SWG, IT CAME APART. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC KIT: 2-LUMEN 12 FR X 6IN (16 CM) | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | LFJ | ARROW INTL., INC. | RF0035124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |