MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-01 for J TIP NEEDLE-FREE INJECTION SYSTEM WITH LUER ADAPTER manufactured by National Medical Products, Inc..
[1470673]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017751 |
| MDR Report Key | 1876144 |
| Date Received | 2010-10-01 |
| Date of Report | 2010-10-01 |
| Date of Event | 2010-09-20 |
| Date Added to Maude | 2010-11-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J TIP NEEDLE-FREE INJECTION SYSTEM WITH LUER ADAPTER |
| Generic Name | J TIP |
| Product Code | KZE |
| Date Received | 2010-10-01 |
| Lot Number | 1003001 |
| Device Expiration Date | 2012-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL PRODUCTS, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-01 |