MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE TUBE 4 ML FX SODIUM FLUORIDE / POTASSIUM OXALATE 13X75; EVACUATED BLOOD COLLECTION TUBE

Model Number 454297

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Dates of event could not be obtained form the customer.Samples were received and forwarded for investigation to the manufacturer, where we purchase the product from.As soon as the investigation is completed, a supplemental report will be filed.

Event Description

Customer states having problem with the tubes and extra anticoagulant powder not mixing with the blood specimen.Often the gray powder floats at the top of the tube even after multiple inversions and centrifugation.All tubes are affected.Customer advises they always mix appropriately.Once they centrifuge there is still some powder that is not absorbed.No photos available but will try to get pictures of issue.

Manufacturer Narrative

Received 1rk 454297/a200536p for evaluation.We have no further complaints on the material/batch.We have no further inventory of the material/batch.We forwarded the complaint and customer samples to our affiliated headquarters in austria from which we receive this product.According to their investigation and comments, a review of the production records revealed no deviations which could be linked to the reported error.Samples were examined.The measured parameters of the draw volume and the amount of additive were within tolerance.The solubility of the powder was checked and after two minutes of inversion of samples, the powder was visibly dissolved in water.Therefore, the complaint is not confirmed.

• Brand Name: VACUETTE TUBE 4 ML FX SODIUM FLUORIDE / POTASSIUM OXALATE 13X75
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller str. 32; kremsmuenster, upper austria 4550 ; AU 4550
• MDR Report Key: 11312115
• MDR Text Key: 258296645
• Report Number: 8020040-2021-00009
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K971239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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: 08/28/2021
• Device Model Number: 454297
• Device Catalogue Number: 454297
• Device Lot Number: A200536P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1