FDA Adverse Event
Malfunction
Summary report: N
HEMODIALYSIS KIT: 2-L 15 FR X 24 CM
MDR report key: 2080067
·
Received April 7, 2011
Report
- Report Number
- 1036844-2011-00117
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 28, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- MSD
- PMA / PMN Number
- K040078
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVENT OCCURRED IN THE THEATRE. WHEN THE CATHETER WAS BEING FLUSHED JUST PRIOR TO DIALYSIS BEING COMMENDED, THEY REALIZED THAT THE BLUE HUB WAS LEAKING AND THE PIGTAILS NEEDED TO BE REPLACED. A REPAIR KIT WAS USED SUCCESSFULLY AND DIALYSIS OCCURRED THE NEXT DAY. THERE WAS NO REPORTED HARM TO THE PT DUE TO THIS ONE DAY DELAY. THERE WERE NO REPORTED INJURIES OR COMPLICATIONS AND NO PT DEATH. THE PRODUCT HAD BEEN INSERTED ON (B)(4), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMODIALYSIS KIT: 2-L 15 FR X 24 CM | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | MSD | ARROW INTERNATIONAL INC | RF0105353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |