FDA Adverse Event
Malfunction
Summary report: N
AVANOS
MDR report key: 21157697
·
Received January 15, 2025
Report
- Report Number
- 21157697
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 11, 2024
- Report Date
- December 23, 2024
- Manufacturer
- AVANOS MEDICAL, INC.
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
REGISTERED NURSE (RN) NEEDED TO REPLACE A NASOGASTRIC (NG) TUBE ON HER PATIENT. THE NURSE OPTED TO REMOVE THE STYLET FROM THE NASOGASTRIC TUBE PRIOR TO INSERTING THE TUBE INTO THE PATIENT. THE GUIDE WIRE HUB WAS STUCK/FUSED/ADHERED TO THE HUB OF THE NG TUBE AND WAS UNABLE TO BE REMOVED. HAD THE RN CHOSEN TO UTILIZE THE GUIDE WIRE DURING PLACEMENT INSTEAD OF REMOVING IT PRIOR TO, THE RN WOULD HAVE HAD TO REMOVE THE TUBE ONCE PLACED AND REPEAT PLACEMENT A SECOND TIME CAUSING UNNECESSARY TRAUMA TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 931809 | AVANOS | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | AVANOS MEDICAL, INC. | 40-9226 | 3032375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |