FDA Adverse Event
Malfunction
Summary report: N
HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
MDR report key: 3823744
·
Received February 20, 2014
Report
- Report Number
- 1036844-2014-00073
- 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 UNRAVELED DURING INSERTION. 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 ACUTE RENAL FAILURE. THE SWG WAS REMOVED AND A NEW 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 |
|---|---|---|---|---|---|---|---|
| 106641 | HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM | ACUTE HEMODIALYSIS CATHETER PRODUCTS | MPB | ARROW INTL., INC. | RF3013957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |