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

Model Number 456087P

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Some of the green 5ml lh lithium heparin tubes have yellow indicator caps off.

• Brand Name: VACUETTE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 4238 capital dr.; monroe NC 28110
• MDR Report Key: 7147310
• MDR Text Key: 95806768
• Report Number: 7147310
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/26/2019
• Device Model Number: 456087P
• Device Catalogue Number: 456087P
• Device Lot Number: B171035F
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1