MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100; EVACUATED BLOOD COLLECTION TUBE

Model Number 455071P

Device Problem Output Problem (3005)

Patient Problem Hemolysis (1886)

Event Type  malfunction  

Manufacturer Narrative

Complaint statement (b)(4).No customer samples were provided.Received customer pictures.We have no remaining inventory of the material/batch.We have no further complaints for the material/batch.We forwarded the complaint and customer pictures to our headquarters in austria from which we receive this product.According to their investigation and comments, a review of production documentation did not reveal any deviations which could be associated with the complained error.The cause of the alleged event cannot be determined.

Event Description

Customer states hemolysis.The tests were ran on 2 separate patients, 2 different psr [phlebotomists], both normal draws, both clotted 30+ minutes, centrifuge settings verified.

• Brand Name: VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller str. 32; kremsmuenster, upper austria 4550 ; AU 4550
• 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: 15154745
• MDR Text Key: 305045626
• Report Number: 8020040-2022-00020
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960858
• 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
• Device Expiration Date: 08/03/2023
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Device Lot Number: A22023BW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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