J-TIP NEEDLE FREE INJECTOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-24 for J-TIP NEEDLE FREE INJECTOR manufactured by National Medical Products, Inc..

Event Text Entries

[19996309] On (b)(6) 2012, 13:39, (b)(6) previously healthy girl presented to mgh ed with possible episode of seizure x 2. Assessed by md. At 16:00 an rn administers a j-tip to the pt's right hand. After approximately one minute, she attempted an iv, got flash, but was ultimately not able to start the iv. At 16:08 a second j-tip was administered by another rn in the left antecubital. She states she positioned the j-tip 2-3 cm distally to where she intended to start the iv as she was concerned the wheal may obscure the vein. The iv was started approximately 1-2 minutes after the j-tip was administered. At 18:00 lab reports positive for lidocaine toxicity (5468 mcg/l ref. Range: 1500-5000 toxic: >6000). Lab ran second report on first sample, which reportedly still came back at toxic levels (approximately 10 mcg/l less than previous report). At 18:55, repeat tox screen drawn from iv site. At 19:56 lab report negative for lidocaine toxicity. (<150 mcg/l ref. Range: 1500-5000 toxic: >6000). At 20:40 pt transported to inpatient floor. Strength: 2 mg 1% lidocaine buffered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5025181
• MDR Report Key: 2553738
• Date Received: 2012-04-24
• Date of Report: 2012-04-24
• Date of Event: 2012-04-19
• Date Added to Maude: 2012-05-01
• 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 Details

• Brand Name: J-TIP NEEDLE FREE INJECTOR
• Generic Name: INJECTOR
• Product Code: KZE
• Date Received: 2012-04-24
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NATIONAL MEDICAL PRODUCTS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	2012-04-24