FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 2-LUMEN 15 FR X 23 CM
MDR report key: 2080102
·
Received April 7, 2011
Report
- Report Number
- 1036844-2011-00113
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- MSD
- PMA / PMN Number
- K040666
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
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 A MALE PT WAS LEAVING THE OPERATING ROOM (OR) WHEN IT WAS NOTED THAT THE DRESSING WAS BLOOD SOILED AT THE INSERTION SITE. ON OPENING THE HUB, WHICH WAS DRESSED IN THE INTENSIVE CARE UNIT, IT WAS NOTED THAT THERE WAS A CRACK ON BOTH SIDES OF THE TRANSPARENT LUMEN WITH THE RED LUER LOCK CONNECTION. ANOTHER CANNON PERMANENT CATHETER WAS OBTAINED FROM THE OR (B)(4) AND OPENED. ONLY THE EXTERNAL HUB CONNECTION WAS USED TO REPAIR THE PERMANENT CATHETER AND DIALYSIS COULD TAKE PLACE AS PLANNED. THERE WERE NO PT DEATH INJURIES OR COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC KIT: 2-LUMEN 15 FR X 23 CM | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | MSD | ARROW INTERNATIONAL INC | RF-1019766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |