MAUDE Adverse Event Report: GREINER BIO-ONE BRAZIL PRODUTOS MEDICOS HOSPITALAR VACUETTE TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR16X100 RED CAP-YELLOW RING; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 455071P

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint number: (b)(4).We received (b)(6) for evaluation.Received customer pictures.We have no further inventory of the material/batch.We forwarded the complaint, samples, and customer pictures to our supplier for their investigation and comments.A review of the historical product record revealed no abnormalities in relation to the reported event.Customer samples were analyzed.Testing consist of draw volume, additive concentration, gel functionality, and visually examined for the additive spray pattern.All results meet the specification.The complaint cannot be duplicated.

Event Description

Customer states there is insufficient gel separation.Notification was from a bio-med employee of saint lukes that performs maintenance and spin in a hettich rotofix 32a - set at 2900 rcf for 10 minutes.Ifu was provided to bio-med employee and customer.Insufficient gel separation was the description given by the bio-med rep.They are actually concerned with the rbcs within the gel, the blood underneath the stopper, and "floating rbcs within the serum.No mention was made concerning fibrin.

• Brand Name: VACUETTE TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR16X100 RED CAP-YELLOW RING
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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 MO 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive,; monroe, NC 28110 ; 7042617800
• MDR Report Key: 10609669
• MDR Text Key: 213251723
• Report Number: 3005674478-2020-00002
• 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: 09/30/2020

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 Expiration Date: 10/20/2021
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Device Lot Number: C200534K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1