MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE TUBES 5ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 456087

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint: (b)(4).We received 1rk and 39 loose pc 456087 /b15123mf for evaluation.We have no further inventory of the material/batch.We have no further complaints on the material/batch.No visual deviation in fill volume, sporadic low or high fill, could be observed in the tested samples.All tubes tested filled within the +/-10% tolerance range.Samples were checked for potassium content and none could be detected.No deviations could be observed on the samples.The complaint cannot be confirmed.

Event Description

Customer states that they are having intermittent issues with high potassium levels.The problematic samples are not hemolyzed, or only have a low hemolysis index.Specimens are primarily collected by straight needles.Other affiliated facilities are using the same lot number, but are not having issues.The same phlebotomist draws samples at other facilities as well, but is not encountering the high potassium issue.Gold top tubes drawn with the psts also give high potassium results.The site having issues has.Switched to a different lot number and has also replaced their centrifuge.Phlebotomist was observed during collection to ensure proper technique and order of draw were being followed.Psts are drawn, mixed, centrifuged immediately and stored upright in a tube rack until transport.When transported, there is no delay in receipt or exposure to excessive heat or cold.

• Brand Name: VACUETTE TUBES 5ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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 ; 7042617800
• MDR Report Key: 10648493
• MDR Text Key: 212809121
• Report Number: 1125230-2016-00004
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: 456087
• Device Catalogue Number: 456087
• Device Lot Number: B15123MF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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