FDA Adverse Event
Malfunction
Summary report: N
MIC GASTRO-ENTERIC FEEDING TUBE
MDR report key: 3140814
·
Received May 24, 2013
Report
- Report Number
- MW5030346
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 24, 2013
- Manufacturer
- KIMBERLY-CLARK
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
COULD NOT REMOVE THE GUIDEWIRE FROM THE FEEDING TUBE. FURTHER INVESTIGATION DISCOVERED A WEAKENED, PARTIALLY COMPRESSED AREA AT THE MID-DISTAL PORTION OF THE TUBE. DIAGNOSIS OR REASON FOR USE: NUTRITIONAL TRAUMA MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231096 | MIC GASTRO-ENTERIC FEEDING TUBE | FEEDING TUBE | KNT | KIMBERLY-CLARK | 0210-20 | AA2032E03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |