MAUDE Adverse Event Report: ARGON MEDICAL DEVICES HAWKINS II; 20 GAUGE 5 CM NEEDLE LOCALIZATION WIRE

Lot Number 11061821

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2014

Event Type  Injury  

Event Description

During routine needle localization procedure, using hawkins ii needle during routine passage of wire out end of needle to lock (secure) in place, the wire broke off unexpectedly.

• Brand Name: HAWKINS II
• Type of Device: 20 GAUGE 5 CM NEEDLE LOCALIZATION WIRE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 5600 tennyson pkwy.; ste 335; plano TX 75024
• MDR Report Key: 3901589
• MDR Text Key: 4674667
• Report Number: 3901589
• Device Sequence Number: 1
• Product Code: GDM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Lot Number: 11061821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2014
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/25/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR