FDA Adverse Event
Malfunction
Summary report: N
HEMODIALYSIS KIT: 2-L 15 FR X 55 CM
MDR report key: 1063688
·
Received June 20, 2008
Report
- Report Number
- 1036844-2008-00094
- Event Type
- Malfunction
- Date Received
- June 20, 2008
- Date of Event
- May 29, 2008
- Report Date
- June 20, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- MSD
- PMA / PMN Number
- K040078
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THIS EVENT INVOLVED A MALE PT VIA RIGHT INTERNAL JUGULAR INSERTION. THE PHYSICIAN PLACED THE CATHETER WITHOUT EVENT. AFTER THE HUB HAD BEEN ATTACHED TO THE CATHETER, THE PHYSICIAN FLUSHED THE CATHETER. HE NOTED "SEVERE" LEAKING FROM THE MIDDLE OF THE HUB. AS A RESULT, THE PHYSICIAN REPLACED ONLY THE HUB WITHOUT EVENT. THERE WERE NO REPORTED PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMODIALYSIS KIT: 2-L 15 FR X 55 CM | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | MSD | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |