MAUDE Adverse Event Report: GREINER BIO-ONE NORTH AMERICA, INC. VACUETTE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450082
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Blood collection set twists back onto itself causing the phlebotomist to have to hold the collection set while attempting to withdraw needle.Needle does not retract completely as designed.

• Brand Name: VACUETTE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE NORTH AMERICA, INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 8088601
• Report Number: 8088601
• Device Sequence Number: 1501973
• Product Code: FMI
• UDI-Device Identifier: 19120017570247
• UDI-Public: (01)19120017570247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/16/2018
• Report Date (Section F): 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 450082
• Device Catalogue Number: 450082
• Device Lot Number: 17L03U
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/16/2018