MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE BLOOD COLLECTION TUBES EDTA; EVACUATED BLOOD COLLECTION TUBE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).No samples received for evaluation.No pictures received.No material # nor batch # was provided by the customer.No clarification or further information was received from the customer.Unfortunately, without basic information, a thorough investigation is not possible.This complaint is closed as cannot be determined due to insufficient information.

Event Description

Customer states increase in clumped platelets and clotted samples since switching to greiner lavender top tubes, especially with outreach work.When reviewing the slide (peripheral blood smear) they see micro-clumps,.2, 3-4 platelets sticking together.The instrument does not flag these but (they) will go and perform a fluorescent platelet under the microscope if needed.Not all sites have this option to perform fluorescent platelet.

• Brand Name: VACUETTE BLOOD COLLECTION TUBES EDTA
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer (Section G): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617823
• MDR Report Key: 10951725
• MDR Text Key: 229077839
• Report Number: 1125230-2020-00067
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1