NEURO-TRACE NEEDLE 553-23-04 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-02-09 for NEURO-TRACE NEEDLE 553-23-04 * manufactured by Hdc Corp..

Event Text Entries

[348529] "tubing becomes dislodged from needle causing loss of medication. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2925153-2005-00022
• MDR Report Key: 571244
• Report Source: 08
• Date Received: 2005-02-09
• Date of Report: 2005-02-08
• Device Manufacturer Date: 2003-08-01
• Date Added to Maude: 2005-02-10
• 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: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 628 GIBRALTAR COURT
• Manufacturer City: MILPITAS CA 95035
• Manufacturer Country: US
• Manufacturer Postal: 95035
• Manufacturer Phone: 4089427340
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEURO-TRACE NEEDLE
• Generic Name: NEURO-TRACE NEEDLE
• Product Code: HAS
• Date Received: 2005-02-09
• Model Number: 553-23-04
• Catalog Number: *
• Lot Number: 1099
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NA
• Device Eval'ed by Mfgr: Y
• Implant Flag: Y
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 561094
• Manufacturer: HDC CORP.
• Manufacturer Address: 628 GIBRALTAR CT. MILPITAS CA 95035 US
• Baseline Brand Name: NEURO-TRACE NEEDLE
• Baseline Generic Name: NEURO-TRACE NEEDLE
• Baseline Model No: 553-23-04
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-02-09