FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
MDR report key: 2201317
·
Received August 3, 2011
Report
- Report Number
- 1036844-2011-00266
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 10, 2011
- Report Date
- August 3, 2011
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- FOZ
- PMA / PMN Number
- K071538
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVENT OCCURRED IN THE TRAUMA UNIT WHILE PLACING THE CATHETER INTO THE PT'S FEMORAL. WHEN TRYING TO REMOVE THE SPRING WIRE GUIDE (SWG) FROM THE CATHETER, THE WIRE BECAME KINKED. AN UPDATE REPORTED ON 07/18/2011 THAT THE LINE WAS PLACED AND THE SWG WAS SUCCESSFULLY, AND IN ITS ENTIRETY, REMOVED. HOWEVER, UPON REMOVAL THE SWG "BENT" AND "CRACKED." A SECOND KIT WAS NOT NEEDED. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT. ADDITIONAL INFORMATION RECEIVED ON 07/28/2011 FROM THE SALES REPRESENTATIVE STATED THE SWG UNRAVELED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 | ARROWG+ARD CATHETER PRODUCTS | FOZ | ARROW INTERNATIONAL INC | RF0062158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |