MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE 4ML FX SODFL/POTOX NR GRY/BLK 13X75; EVACUATED BLOOD COLLECTION TUBE

Model Number 454297

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Received 1cs 454297/a19043cf for evaluation.No samples of 454297/a190249p were received for evaluation.We have no further complaints on the material/batches.We forwarded the complaint and samples to our affiliated headquarters in (b)(4) from which we receive this product.According to their investigation and comments, an inspection of retain samples of batch a190249p was performed.No deviations related to the reported error could be detected.Customer samples of batch a19043cf were inspected.No irregularity which would lead to the complaint issue of clotted samples could be detected.The complaint could not be duplicated on the retain or customer samples which were evaluated.However, we acknowledge the possibility for occurrence.Therefore, additional visual inspection with a defined sampling interval regarding amount of powder in the tube was implemented at the concerned assembly lines.Complaints will continue to be monitored.

Event Description

Customer states 30-40% of tubes are clotted.This occurs with different phlebotomists at different locations.

Manufacturer Narrative

Manufacturer' narrative: we could not obtain a date of event.The mdr is submitted retrospectively.

• Brand Name: VACUETTE 4ML FX SODFL/POTOX NR GRY/BLK 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: 10819719
• MDR Text Key: 251001845
• Report Number: 8020040-2019-00018
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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: 08/03/2020
• Device Model Number: 454297
• Device Catalogue Number: 454297
• Device Lot Number: A190249P, A19043CF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1