MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED; EVACUATED BLOOD COLLECTION

Model Number 454209

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint statement (b)(4): no samples were received for evaluation.No batch number was provided.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 seeing an increase in the mcv on short draws.When recollected with adequate amount of blood the mcv decreases back to where the patient normally runs [mcv].

• Brand Name: VACUETTE TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED
• Type of Device: EVACUATED BLOOD COLLECTION
• 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: 10870351
• MDR Text Key: 253305027
• Report Number: 1125230-2020-00054
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971236
• 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: 11/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 454209
• Device Catalogue Number: 454209
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/19/2020
• 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