MAUDE Adverse Event Report: MEDLINE 25 G NEEDLE

Model Number DYNJ06653688

Device Problems Break (1069); Component Falling (1105)

Patient Problem Unspecified Infection (1930)

Event Date 04/18/2017

Event Type  Injury  

Event Description

The surgeon was injecting into the shoulder with the 25 gauge needle when the needle broke in half.The surgeon was able to remove it with a clamp.Medline complaint number: (b)(4).Dates of use: (b)(6) 2017.Diagnosis or reason for use: infection into the shoulder during a surgical procedure.

• Brand Name: 25 G NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): MEDLINE ; 1170 north point blvd; medline b04; waukegan IL 60045
• MDR Report Key: 6577944
• MDR Text Key: 75607523
• Report Number: MW5069866
• Device Sequence Number: 1
• Product Code: FSH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ06653688
• Device Lot Number: 16FK0624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention