FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 2-LUMEN 7 FR X 60 CM
MDR report key: 3050239
·
Received April 5, 2013
Report
- Report Number
- 1036844-2013-00130
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 29, 2013
- Report Date
- April 4, 2013
- 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 INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE (B)(6) MALE PATIENT'S ROOM, 13 DAYS AFTER THE PLACEMENT OF THE CATHETER IN THE PATIENT'S RIGHT FEMORAL VEIN, THE CATHETER MIGRATED OUT OF THE PATIENT'S BODY. AS A RESULT, THAT CATHETER WAS REMOVED BUT NOT REPLACED, INSTEAD THE PATIENT'S CONDITION IS BEING MONITORED TO DECIDE ON THE NECESSITY OF FURTHER TREATMENT. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT. THE PATIENT IS "GOOD". SEE 1036844-2013-00131 FOR SECOND COMPLAINT RELATED TO THE SAME CATHETER BEING CUT INTO TWO PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141931 | CVC KIT: 2-LUMEN 7 FR X 60 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTL., INC. | RF2083143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |