FDA Adverse Event
Malfunction
Summary report: N
PRAXIJECT SP 0.9% NACL
MDR report key: 20951100
·
Received December 17, 2024
Report
- Report Number
- 20951100
- Event Type
- Malfunction
- Date Received
- December 17, 2024
- Date of Event
- November 19, 2024
- Report Date
- November 29, 2024
- Manufacturer
- MEDXL INC
- Product Code
- NGT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
WHILE ATTEMPTING TO NS FLUSH THE PATIENT'S MIDLINE, THE PLUNGER OF THE NS FLUSH BENT, AND A PIECE OF THE PLASTIC BROKE OFF. NO HARM TO STAFF OR PATIENT. MIDLINE NOTED TO BE OCCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1457360 | PRAXIJECT SP 0.9% NACL | SALINE, VASCULAR ACCESS FLUSH | NGT | MEDXL INC | 3705-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |