FDA Adverse Event
Malfunction
Summary report: N
INDURA CATHETER
MDR report key: 1041240
·
Received May 9, 2008
Report
- Report Number
- 6000030-2008-02504
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 9, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP CONNECTOR MAY BE DISCONNECTED PER X-RAY REPORTS. IN LATE 2007, THE HCP REPORTED DIFFICULTIES REFILLING THE PUMP. THE PUMP WAS FOUND TO BE FLIPPED AND WAS MANUALLY ROTATED BACK INTO PLACE. NO SYMPTOMS WERE REPORTED BETWEEN THE TIME OF THE PUMP EVENT AND THE CONNECTOR DISCONNECT. THE PUMP IS CURRENTLY FILLED WITH SALINE AND WIL BE REVISED AT AN UNSPECIFIED DATE. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA CATHETER | LKK | RICE CREEK MANUFACTURING | 8709 | N074614019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOT# NGH055933R| PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 8627L18 |