FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN CVC KIT: 2-L 7 FR X 6IN 16C
MDR report key: 2934930
·
Received January 25, 2013
Report
- Report Number
- 2242445-2013-00012
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- December 16, 2012
- Report Date
- January 25, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K82056
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED IN THE OPERATING ROOM. THE PHYSICIAN STATED THAT ONE OF HIS COLLEAGUES CUT HIS FINGERS WHEN CRACKING THE TINCTURE OF BENZOINE APPLICATOR VIAL LOCATED IN THE POUCH WITH THE STATLOCK DEVICE. THE CLINICIAN WENT TO THE ER FOR STITCHES DUE TO A CUT. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36093 | MULTI-LUMEN CVC KIT: 2-L 7 FR X 6IN 16C | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |