MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-29 for J-TIP SYRINGE J-TIP .50 ML manufactured by National Medical Products, Inc..
[1759578]
Nurse went to apply j-tip. States she applied j-tip appropriately and the lidocaine sprayed at lease 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
[8873093]
Product problem type has never before been reported - over 4 million units distributed. Discussion with reporting nurse she stated it was a user error as well as medwatch report copied to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027063-2010-00001 |
| MDR Report Key | 1943500 |
| Report Source | 05,06 |
| Date Received | 2010-10-29 |
| Date of Report | 2010-10-29 |
| Date of Event | 2010-09-20 |
| Date Mfgr Received | 2010-10-08 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2011-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHERYL BLAKE |
| Manufacturer Street | 57 PARKER ST. |
| Manufacturer City | IRVINE CA 92718 |
| Manufacturer Country | US |
| Manufacturer Postal | 92718 |
| Manufacturer Phone | 9492853517 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J-TIP SYRINGE |
| Generic Name | SYRINGE, NEEDLELESS |
| Product Code | KZE |
| Date Received | 2010-10-29 |
| Model Number | J-TIP .50 ML |
| Catalog Number | J-TIP .50 ML |
| Lot Number | 1003001 |
| Device Expiration Date | 2012-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 57 PARKER ST. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-29 |