MAUDE Adverse Event Report: BD VACUTAINER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 367342

Device Problems Fluid/Blood Leak (1250); Retraction Problem (1536); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

A butterfly needle retracted after completing a blood draw and the needle did not retract all the way back.The needle partially retracted and began squirting the blood out of the needle.There was no needlestick or injury to the employee or patient.

• Brand Name: VACUTAINER
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 4371106
• MDR Text Key: 5290612
• Report Number: 4371106
• Device Sequence Number: 1
• Product Code: JKA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/30/2014
• Patient Sequence Number: 1