MAUDE Adverse Event Report: GREINER BIO-ONE BRAZIL PRODUTOS MEDICOS HOSPITALAR VACUETTE BLOOD COLLECTION TUBES EDTA; EVACUATED BLOOD COLLECTION TUBE

Device Problem Inability to Auto-Fill (1044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complaint statement (b)(4): no samples were received for evaluation.Received customer pictures.No material number nor batch number was provided by the customer.No clarification or further information was provided by the customer.Unfortunately, without basic information, a thorough investigation is not possible.The cause of the alleged event cannot be determined due to insufficient information.

Event Description

Customer states lavender tubes are not filling up.They removed the lot from the floor and the results were much better.Customer provided photos of the lot in question vs the new lot.

• Brand Name: VACUETTE BLOOD COLLECTION TUBES EDTA
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE BRAZIL PRODUTOS MEDICOS HOSPITALAR; av. affonso pansan, 1967; americana, sao paulo 13473 -620; BR 13473-620
• 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: 15154827
• MDR Text Key: 304969197
• Report Number: 3005674478-2022-00005
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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: 07/12/2022
• 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