FDA Adverse Event
Malfunction
Summary report: N
HEMODIALYSIS TWO-LUMEN KIT: 2-L 28FR
MDR report key: 3021032
·
Received March 20, 2013
Report
- Report Number
- 1036844-2013-00098
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 21, 2013
- Report Date
- March 18, 2013
- Manufacturer
- ARROW INTL., 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 IN DIALYSIS, THE EXTENSION LINE OF THE CATHETER CRACKED AND AS A RESULT, THE NORMAL DIALYSIS COULD NOT BE PERFORMED. A REPLACEMENT KIT WAS USED AND DIALYSIS WAS SUCCESSFULLY COMPLETED. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO HARM TO THE PT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116262 | HEMODIALYSIS TWO-LUMEN KIT: 2-L 28FR | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | MSD | ARROW INTL., INC. | RF2032762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |