FDA Adverse Event
Malfunction
Summary report: N
2-DAY INFUSION KIT W/4.16 CC/H
MDR report key: 1713028
·
Received August 31, 2009
Report
- Report Number
- 1811755-2009-00398
- Event Type
- Malfunction
- Date Received
- August 31, 2009
- Date of Event
- March 7, 2007
- Report Date
- March 7, 2007
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- MEB
- PMA / PMN Number
- K042405
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AS OF 08/11/2009 THE CATHETER HAS NOT BEEN RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
DURING THE INITIAL REPORT THE SALES REP REPORTED THAT A CATHETER BROKE OFF IN A PT. DURING A FOLLOW UP REPORT, IT WAS REPORTED BY THE CUSTOMER THAT DURING A BREAST AUGMENTATION PROCEDURE A CATHETER WAS PLACED SUBMUSCULAR. IT WAS REPORTED THAT THE DOCTOR REMOVED THE CATHETER AND RESISTANCE WAS FELT DURING REMOVAL. THE CATHETER WAS NOT DETECTED IN X-RAY. IT WAS REPORTED BY THE CUSTOMER NO ACTION WAS TAKEN DUE TO THIS EVENT AND THE CATHETER WAS LUBRICATED WITH 1% LIDOCAINE WHICH WAS INJECTED INTO THE CATHETER TO FLUSH IT ONCE RESISTANCE WAS FELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2-DAY INFUSION KIT W/4.16 CC/H | PUMP, INFUSION | MEB | STRYKER INSTRUMENTS KALAMAZOO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |