MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE TUBE 5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X100; EVACUATED BLOOD COLLECTION TUBE

Model Number 456018P

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer states excessive crystallization with their chemistry analyzer in tubing and connectors since switched to greiner tubes.They never had this happen before.They recently had to have parts replaced on both chemistry analyzers that are normally not replaced because they had so much crystallization that it was affecting the qc and patient results.They are looking for a different kind of centrifuge that they can purchase that may help with this, of course this is an additional expense to try to keep this from occurring again.Customer states this would be a manifestation from all lots used over the past year since changing to greiner tubes.Their current tube most frequently used on this analyzer is 456018p, lot b20103ea.The centrifuge is thermo fisher scientific sorvall st 16 for 2952 rcf for 10 minutes.The analyzers are the siemens exl lm and exl 200.The field service rep stated that this is crystallization that he had not experienced previously, especially at their facility.The crystallization occurred on parts that are normally only cleaned at service pms and not replaced.These were so excessing that they were replaced not just cleaned.The field service rep asked what had changed since their service a year ago and the only change has been the switch to greiner tubes.He recommended reporting to greiner, increasing the centrifuge time, and monitoring for crystallization.The parts were disposed of.No photos available.

Manufacturer Narrative

Received 1rk 456018p/b20103ea for evaluation.We have no further complaints on the material/batch.A check of quality, production, and maintenance records revealed no deviations in relation to the reported event.Customer 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.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.Therefore, the complaint is not confirmed.Corrected data: h3: samples received; h6 type of investigation, investigation findings, investigation conclusion; h10: manufacturer narrative.

• Brand Name: VACUETTE TUBE 5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 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: 11395139
• MDR Text Key: 247672958
• Report Number: 1125230-2021-00017
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K983952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: 456018P
• Device Catalogue Number: 456018P
• Device Lot Number: B20103EA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1