FDA Adverse Event
Other
Summary report: N
SERVO-I
MDR report key: 2824528
·
Received October 26, 2012
Report
- Report Number
- 8010042-2012-00124
- Event Type
- Other
- Date Received
- October 26, 2012
- Date of Event
- September 24, 2012
- Report Date
- September 28, 2012
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ON REMOVAL OF THE EDI CATHETER, IT WAS FOUND THAT SOME PARTS WERE MISSING. AFTER AN UNSUCCESSFUL GASTROSCOPIC PROCEDURE TO REMOVE THE MISSING PARTS, THE PARTS WERE FINALLY REMOVED USING A NET. THE EDI CATHETER HAD BEEN IN USE FOR 17 DAYS. THERE WAS NO HARM TO THE PT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO-I | CBK | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |