FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN CVC KIT: 2-L 7 FR X 8IN (20 C
MDR report key: 2904037
·
Received January 3, 2013
Report
- Report Number
- 1036844-2013-00002
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 1, 2012
- Report Date
- January 3, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQY
- PMA / PMN Number
- K820648
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
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 THERE WAS A LEAK FOUND FROM THE FEMALE LUER OF THE STOPCOCK. THE LEAK WAS FOUND, ROUGHLY 2 WEEKS AFTER PLACING THE CATHETER AND TWO DAYS AFTER SWITCHING MEDICAL SOLUTION TO 5-FU. THE STOPCOCK WAS REPLACED AND A NEW ONE WAS USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2148 | MULTI-LUMEN CVC KIT: 2-L 7 FR X 8IN (20 C | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTL., INC. | RF2072302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |