FDA Adverse Event
Malfunction
Summary report: N
COMPANION SET
MDR report key: 2193120
·
Received July 21, 2011
Report
- Report Number
- 1527460-2011-00050
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 24, 2011
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- KNT
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE REPORTED, LIST NUMBER 00071, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 00071, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED AN UNDER-DELIVERY. A 115 ML OF FEEDING WAS HUNG. THE FEEDING SET RATE WAS 150 ML, AND THE SET DOSE ON THE PUMP WAS 115 ML. HOWEVER, 40 ML WAS DELIVERED IN 1 HOUR WHEN MEASURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPANION SET | KNT, TUBES GASTROINTESTINAL AND ACCESSORIES | KNT | ABBOTT NUTRITION | 00071 | 01338LE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |