J-TIP NEEDLE FREE INJECTION SYSTEM . 2ML

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-16 for J-TIP NEEDLE FREE INJECTION SYSTEM . 2ML manufactured by National Medicla Products, Inc..

Event Text Entries

[16321362] A (b)(6) male with a pmhx significant for spherocytosis presented to the ed on (b)(6), with ataxia. He was administered a j-tip in the r ac prior to iv start at 23:22. Labs were sent and the tox screen came back positive for lidocaine toxic level of 7238, range of 1500-5000 and clonazepam. A second tox screen was sent at 04:45 which came back negative for lidocaine. Of note, the pt was transferred to the picu for a code event at 4:45 where he became unresponsive. This occurred shortly after the 2nd set of labs were drawn for repeat tox screen. Hpi: mother takes gapapentin, klopazepam, topamax; (b)(6) lives in house also while she is dealing with cancer, has many meds that mom doesn't know of, but keeps them all up as well. Pmhx/pshx: spherocytosis, followed by primary care, dx with yellow eyes at an ophtho visit last year.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5025439
• MDR Report Key: 2583825
• Date Received: 2012-05-16
• Date of Report: 2012-05-16
• Date of Event: 2012-05-14
• Date Added to Maude: 2012-05-24
• 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: 0
• 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

Device Sequence Number: 1

• Brand Name: J-TIP NEEDLE FREE INJECTION SYSTEM . 2ML
• Generic Name: J-TIP 1%
• Product Code: KZE
• Date Received: 2012-05-16
• Lot Number: 05102012@552
• ID Number: 0000000
• Device Expiration Date: 2012-06-09
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NATIONAL MEDICLA PRODUCTS, INC.
• Manufacturer Address: 57 PARKER ST IRVINE CA 92618114 US 92618 1147

Device Sequence Number: 2

• Brand Name: J-TIP NEEDLE FREE INJECTION SYSTEM .2ML
• Generic Name: J-TIP 1%
• Product Code: KZE
• Date Received: 2012-05-16
• Lot Number: 04232012@50
• ID Number: 0000000
• Device Expiration Date: 2012-05-23
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: NATIONAL MEDICAL PRODUCTS, INC.
• Manufacturer Address: 57 PARK ST IRVINE CA 92618114 US 92618 1147

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2012-05-16