FDA Adverse Event
Injury
Summary report: N
G-JET GJ TUBE FAMILY
MDR report key: 23276106
·
Received October 14, 2025
Report
- Report Number
- MW5177222
- Event Type
- Injury
- Date Received
- October 14, 2025
- Date of Event
- May 20, 2025
- Report Date
- October 10, 2025
- Manufacturer
- APPLIED MEDICAL TECHNOLOGY, INC.
- Product Code
- KNT
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
A REPORTER CALLED IN ON BEHALF OF BEING THE GUARDIAN OF THIS CHILD WHO USES THIS DEVICE TO ADMINISTER HER MEDICATION AND FOOD. THROUGH THE G-JET GJ TUBE. WHEN CHANGING OUT THE PUMP FOR THE MEDICATION IT BROKE OFF AND BECAME STUCK IN THE PATIENT. THIS PROBLEM CAUSED HER TO BE HOSPITALIZED WHERE SHE IS STILL CURRENTLY DUE TO IT INTERFERING WITH HER RECEIVING HER MEDICATIONS. SHE ALSO RECEIVES FOOD BY USING THIS MEDICAL DEVICE AS WELL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37 | G-JET GJ TUBE FAMILY | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | APPLIED MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 MO | Female | Hospitalization |