FDA Adverse Event
Malfunction
Summary report: N
J TIP NEEDLE-FREE INJECTION SYSTEM WITH LUER ADAPTER
MDR report key: 1876144
·
Received October 1, 2010
Report
- Report Number
- MW5017751
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- September 20, 2010
- Report Date
- October 1, 2010
- Manufacturer
- NATIONAL MEDICAL PRODUCTS, INC.
- Product Code
- KZE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
NURSE WENT TO APPLY J-TIP. STATES SHE APPLIED J-TIP APPROPRIATELY AND THE LIDOCAINE SPRAYED AT LEAST 12 INCHES AND SPLASHED HER IN BOTH EYES. NURSE WAS SEEN IN ASSOCIATE HEALTH DEPARTMENT. NO NEGATIVE SEQUELAE NOTED TO DATE FROM SPLASH INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J TIP NEEDLE-FREE INJECTION SYSTEM WITH LUER ADAPTER | J TIP | KZE | NATIONAL MEDICAL PRODUCTS, INC. | 1003001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |