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

Model Number 455071P

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemolysis (1886)

Event Type  malfunction  

Manufacturer Narrative

Complaint statement (b)(4).No samples were received for evaluation.Received customer pictures.We have no further inventory of the material/batch.We have no further complaints on the material/batch.A check of quality, production, and maintenance records revealed no deviations in relation to the reported error.The complaint cannot be determined.

Event Description

Customer states "the blood sample remains impregnated on the walls of the tube even though the sample is centrifuged with the rpm recommended by the commercial company.Causing the serum to be visualized as "hemolyzed" without being so.Affecting immunological tests, and the formation of fibrin that clogs the equipment needles".

• 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 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: 11871444
• MDR Text Key: 255366994
• Report Number: 1125230-2021-00048
• 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: 05/24/2021

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 Expiration Date: 08/09/2021
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Device Lot Number: B200236F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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