MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 4ML LH LI HEP SEP NR GRN/Y/T; EVACUATED BLOOD COLLECTION TUBE

Model Number 454008P

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Received 1rk 454008p/b19053v5 for evaluation.Received customer data.No samples of the 2nd claimed batch were received.We have no further complaints on the material/batches.A review of quality, production, and maintenance documentation shows no deviations related to the reported issue.Samples were tested, according to gbo standard testing procedures, with regards to correct assembly and additive content according to iso 6710 'single use containers for venous blood specimen collection' and clsi gp39-a6 regulations for 'evacuated tubes and additives for blood specimen collection'.Tubes were verified to be correctly assembled.Additive content was found to be within specification in all tested samples.Samples were checked for potassium content and none could be detected.No deviations could be observed in the samples.Therefore, the complaint is not confirmed.

Event Description

Customer states there have been intermittent high potassium results that upon redraw will be normal.This occurs in approximately 2% of tubes.All other test results are within normal range.All specimens are properly mixed.Tubes are being centrifuged approximately 10-15 minutes after collection at 2700 rpms (1263 rcf) for 10 minutes.The specimens show no signs of hemolysis.

• Brand Name: VACUETTE 4ML LH LI HEP SEP NR GRN/Y/T
• 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: 10819893
• MDR Text Key: 226655808
• Report Number: 1125230-2019-00007
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960857
• 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: 11/10/2020

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: 08/14/2020
• Device Model Number: 454008P
• Device Catalogue Number: 454008P
• Device Lot Number: B19053V5, B190334Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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