MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	454008P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Employee grabbed a vacuette green top sample tube and noticed that product was deformed and could not be used for sample collection.Upon checking other tubes in same lot number, others were found to be defective and non-usable.

• Brand Name: VACUETTE
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 4238 capital drive; monroe NC 28110
• MDR Report Key: 7285309
• Report Number: 7285309
• Device Sequence Number: 1210583
• Product Code: JKA
• UDI-Device Identifier: 29120017579032
• UDI-Public: (01)29120017579032
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2018
• Report Date (Section F): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 01/10/2019
• Device Model Number: 454008P
• Device Catalogue Number: 454008P
• Device Lot Number: B17073N5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2018
• 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: 02/13/2018