FDA Adverse Event
Malfunction
Summary report: N
J-TIP SYRINGE
MDR report key: 2401935
·
Received January 5, 2012
Report
- Report Number
- 2401935
- Event Type
- Malfunction
- Date Received
- January 5, 2012
- Date of Event
- October 12, 2011
- Report Date
- October 28, 2011
- Manufacturer
- NATIONAL MEDICAL PRODUCTS, INC.
- Product Code
- KZE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
THE PRESSURIZED J-TIP SYRINGE BROKE INTO SEVERAL PIECES ON ACTIVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J-TIP SYRINGE | J-TIP 0.25 SYRINGE | KZE | NATIONAL MEDICAL PRODUCTS, INC. | * | NMP LOT # 1104001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |