FDA Adverse Event
Malfunction
Summary report: N
NEOMAGIC
MDR report key: 19547017
·
Received June 17, 2024
Report
- Report Number
- 19547017
- Event Type
- Malfunction
- Date Received
- June 17, 2024
- Date of Event
- February 23, 2024
- Report Date
- March 4, 2024
- 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
ATTEMPTED TO PLACE AN EXTENDED DWELL CATHETER IN BABY'S LEFT SAPHENOUS VEIN, USING NEOMAGIC 1.9 FR SL CATHETER WITH STYLET (LOT 1033). WITH CATHETER INTACT, IT WAS PRIMED WITH A STERILE FLUSH, AS PER PROTOCOL. CATHETER WAS INSERTED TO 6 CM AND STYLET WAS REMOVED. AS CATHETER WAS FLUSHED, IT WAS NOTED THAT THERE WAS A HOLE IN THE CATHETER AT 6.5 CM. CATHETER WAS REMOVED AND A SECOND ATTEMPT WAS MADE WITH A SECOND CATHETER, PREPARED THE SAME WAY. THIS TIME, THE CATHETER WAS INSERTED TO 5 CM, STYLET WAS REMOVED AND CATHETER WAS FLUSHED. AGAIN, A HOLE WAS NOTED IN THE SECOND CATHETER AT 6.5 CM. CATHETER WAS REMOVED, INTRODUCER WAS REMOVED AND INSERTION ATTEMPT WAS UNABLE TO BE COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2338860 | NEOMAGIC | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS | FOZ | NEO MEDICAL INC. | 1943-1608 | 1033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Male |