FDA Adverse Event
Summary report: N
AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS
MDR report key: 16253941
·
Received January 26, 2023
Report
- Report Number
- MW5114528
- Date Received
- January 26, 2023
- Report Date
- January 24, 2023
- Manufacturer
- AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
- Product Code
- KNT
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WE HAVE HAD A COUPLE OF PATIENTS WHO HAVE REQUIRED MORE FREQUENT TUBE REPLACEMENTS THAN NORMAL. THESE PATIENTS BOTH HAVE AVANOS BRAND ENFIT GTUBE OR GJTUBES. ADDITIONAL DEVICE INFORMATION PROVIDED BELOW. LOT 30211447. REF 8250-22; LOT 30213424, REF 8250-22; LOT 301476558, REF 8250-22; LOT 30147658, REF 8250-22; LOT 30175803, REF 8100-20; LOT 30122663, REF 8100-20; LOT 30185787, REF 8100-20; LOT 30113520, REF 8100-20; LOT 30167456, REF 8100-20.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5401 | AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30175803 | ||
| 5402 | AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30122663 | ||
| 5403 | AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30185787 | ||
| 5404 | AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30113520 | ||
| 5405 | AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30167456 | ||
| 5406 | AVANOS MIC G-J FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30211447 | ||
| 5407 | AVANOS MIC G-J FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30213424 | ||
| 5408 | AVANOS MIC G-J FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 301476558 | ||
| 5409 | AVANOS MIC G-J FEEDING TUBE WITH ENFIT CONNECTORS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) | 30147658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |