MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING; EVACUATED BLOOD COLLECTION TUBE

Model Number 456087P

Device Problem Product Quality Problem (1506)

Patient Problem Hemolysis (1886)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).No more inventory of the material and batch is available.Customer samples and additional information was requested.If samples from the customer are received and investigation is completed, a supplement report will be filed.

Event Description

Customer (lab director) states that in the past 2-4 weeks there have been regular issues with hemolysis on this tube.

Manufacturer Narrative

The date of event could not be obtained from the customer.No samples were received for evaluation.Received customer picture.We have no further inventory of the material/batch.No clarification nor further information was received from the customer.A review of quality, production, and maintenance records revealed no deviations related to the reported event.The complaint cannot be determined.

• Brand Name: VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 10922851
• MDR Text Key: 234396555
• Report Number: 1125230-2020-00065
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K960857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: 456087P
• Device Catalogue Number: 456087P
• Device Lot Number: B200849P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1