FDA Adverse Event
Malfunction
Summary report: N
NEOMAGIC
MDR report key: 19816613
·
Received July 24, 2024
Report
- Report Number
- 19816613
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Date of Event
- May 11, 2024
- Report Date
- May 14, 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
AT SHIFT CHANGE WHEN LINES WERE CHECKED AND TRACED, THE EXTENDED DWELL CATHETER (EDC) WAS FUNCTIONING CORRECTLY. WHEN DOING CARE WITH PATIENTS IT WAS NOTED THAT THE EDC LINE HAD SEPARATED FROM THE CATHETER. DRESSING WAS STILL INTACT, AND THE CATHETER SEPARATED JUST DISTAL TO DRESSING. REPORTED TO CLINICAL NURSE (CN) IMMEDIATELY. CN REMOVED EDC, AND NOTED THE ENTIRE CATHETER WAS REMOVED. NO FURTHER COMPLICATIONS WITH INSERTION SITE. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS, NEOMAGIC (PER SITE REPORTER). EMAILED, NO RESPONSE YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355896 | NEOMAGIC | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS | FOZ | NEO MEDICAL INC. | 1943-1608 | 1035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 MO | Female |