FDA Adverse Event
Malfunction
Summary report: N
NEOMAGIC
MDR report key: 23827087
·
Received December 17, 2025
Report
- Report Number
- 23827087
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Date of Event
- November 23, 2025
- Report Date
- November 26, 2025
- Manufacturer
- NEO MEDICAL INC.
- Product Code
- FOZ
- 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
EXTENDED DWELL CATHETER FOUND TO BE LEAKING AT THE HUB WHERE THE CATHETER MEETS THE HARD PLASTIC PART. SKIN WAS WET AND BLANKETS WET UNDERNEATH. PATIENT GLUCOSE VIA HEEL STICK WAS 65. CATHETER WAS DISCONTINUED WITHOUT FURTHER PROBLEMS AND AN ORDER FOR A PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] WAS PLACED AND ATTEMPTS FOR THAT BEGAN. A VIDEO WAS TAKEN OF THE LEAKING CATHETER TO AIDE IN INVESTIGATIONS. THERE WAS NO INSTRUMENTATION USED DURING CATHETER PLACEMENT, NO LOOPS UNDER DRESSING OR OTHER REASONS TO EXPLAIN CAUSE. DRESSING WAS OTHERWISE INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2039883 | NEOMAGIC | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | NEO MEDICAL INC. | 1946-1608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |