FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 3-LUMEN 5.5 FR X 30 CM
MDR report key: 3770461
·
Received February 18, 2014
Report
- Report Number
- 1036844-2014-00059
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Date of Event
- February 3, 2014
- Report Date
- February 3, 2014
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQO
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE RIGHT FEMORAL OF A (B)(6) MALE PT WEIGHING (B)(6) IN THE PICU. THE PHYSICIAN REPORTED THE SPRING WIRE GUIDE HAD "GOTTEN BENT TO PIECES" AS SHE TRIED FEEDING IT BACK THROUGH THE CATHETER. THE WIRE WAS PREVIOUSLY INSERTED THROUGH THE NEEDLE. AS A RESULT, ANOTHER KIT WAS OPENED. SEE MDRS 1036844-2014-00060 AND 1036844-2014-00061 FOR THE SECOND AND THIRD EVENTS WITH THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102288 | CVC KIT: 3-LUMEN 5.5 FR X 30 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQO | ARROW INTL., INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |