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 Problems Product Quality Problem (1506); Device Dislodged or Dislocated (2923)

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 picture.No batch number was provided.No further information/clarification was received.Unfortunately, without basic information, a thorough investigation is not possible.Therefore, a cause of the event cannot be determined.

Event Description

Customer states higher occurrences of poorly spun tubes.The gel is dislodging and not forming a sturdy barrier between the cells and serum.The lab has reported that they have even seen tubes where the gel is free floating in the tube.Picture provided is an example spun by the phlebotomist.It was taken immediately after spinning.

• 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: 14680499
• MDR Text Key: 302071554
• Report Number: 1125230-2022-00025
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1