FDA Adverse Event
Malfunction
Summary report: N
HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
MDR report key: 3823737
·
Received February 20, 2014
Report
- Report Number
- 1036844-2014-00071
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- November 7, 2013
- Report Date
- February 18, 2014
- Manufacturer
- ARROW INTL., INC.
- Product Code
- MPB
- PMA / PMN Number
- K991431
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SWG BENT DURING THE PROCEDURE. THE EVENT OCCURRED IN THE UTI AND THE INSERTION SITE WAS THE SUBCLAVIAN VEIN OF A MALE PT (B)(6). PT HAD A HISTORY OF HEMODIALYSIS NECESSITY. THE SWG WAS REMOVED AND ANOTHER KIT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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 |
|---|---|---|---|---|---|---|---|
| 106691 | HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM | ACUTE HEMODIALYSIS CATHETER PRODUCTS | MPB | ARROW INTL., INC. | RF3038974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |