FDA Adverse Event
Malfunction
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING SET
MDR report key: 2002620
·
Received February 8, 2011
Report
- Report Number
- 1722139-2011-00012
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 18, 2011
- Report Date
- February 8, 2011
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION HOWEVER THE ISSUE WAS CLEARLY EXPLANTED BY THE CUSTOMER. THE REPORTED DEFECT WAS NOTICED DURING PRIMING OF THE SET. THIS COMPLAINT COULD NOT BE VERIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE PRODUCT TUBING WAS ASSEMBLED BACKWARDS CAUSING FLUID TO RUN IN THE OPPOSITE DIRECTION. THE REVERSED TUBING WAS NOTICED WHILE PRIMING THE SET AT THE SET WAS NOT HOOKED UP TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERALITE INFINITY ENTERAL FEEDING SET | KNT | MOOG MEDICAL DEVICES GROUP | INF0500 | CF1024304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |