FDA Adverse Event
Malfunction
Summary report: N
SURGITEK CONTINUOUS FEEDING TUBE, 28 FR RIGHT ANGLE
MDR report key: 12272
·
Received March 25, 1994
Report
- Report Number
- MW1001227
- Event Type
- Malfunction
- Date Received
- March 25, 1994
- Date of Event
- February 19, 1994
- Report Date
- March 14, 1994
- Manufacturer
- MEDICAL ENGINEERING CORP.
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 2/19/94 ONE ADAPTER END OF FEEDING TUBE SEPARATED AT CONNECTION. A SECOND FEEDING TUBE BROKE BEFORE THE CONNECTION. ON 2/21/94, AGAIN THE ADAPTER END OF FEEDING TUBE SEPARATED AT THE CONNECTION AND A THIRD FEEDING TUBE BROKE. (ALSO SEE MW 1001228 AND MW1001229.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGITEK CONTINUOUS FEEDING TUBE, 28 FR RIGHT ANGLE | CONTINUOUS FEEDING TUBE | KNT | MEDICAL ENGINEERING CORP. | 1028001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 MO | Other | SURGITEK GASTROSTOMY BUTTON |