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

Model Number 456087P

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).A date of the event could not be obtained from the customer.Samples were received, but the evaluation is still in progress.As soon as the investigation is completed, a supplemental report will be filed.

Event Description

Customer initially stated they are seeing cellular debris in tubes after centrifugation, as well as sometimes incomplete separation.Customer started seeing issues in the last 6 months.Roche cobas is the analyzer in use and alk phos results, and other tests, are being affected.During a follow-up conversation by greiner with the customer, it was stated that no cellular debris or incomplete separation in tubes after centrifugation has been observed.The analyzer companies maintain that the issue is not caused by the instruments.

Manufacturer Narrative

Received 2rk of 456087p/b210137g for evaluation.Received customer pictures and videos.We have no further complaints on the material/batch.A check of quality, production, and maintenance documents revealed no deviations in relation to the reported error.Samples were tested, according to gbo standard testing procedures, with regards to correct assembly, level mark, filling level, draw volume 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 and had the correct fill guideline position.Greiner fill mark provides a visual control opportunity for the phlebotomist and for the lab personnel to check for proper volume collection of specimen.Both standards specify the draw volume to be within +/- 10% range of the nominal fill volume.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.Additive content was found to be within specification in all tested samples.No deviations could be observed in the tested samples.Some of the samples were evaluated in a blood draw.Samples were centrifuged using recommended gbo parameters within 2 hours.No oily residue on the top surface of the plasma, gel droplets, and fibrin as described by the customer could be observed.The complaint cannot be duplicated on the returned samples.Corrected data: h3: samples received; h6: type of investigation, investigation findings, investigation conclusion.H10: manufacturerer narrative.

• Brand Name: VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 11678954
• MDR Text Key: 248171630
• Report Number: 1125230-2021-00032
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: 456087P
• Device Catalogue Number: 456087P
• Device Lot Number: B210137G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1