MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100; EVACUATED BLOOD COLLECTION TUBE

Model Number 455071P

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).The customer did not provide a date of the event.Samples from the customer have been requested for evaluation.As soon as received and the investigation is completed, we will file a supplemental report.

Event Description

Customer states end-user sends sst tubes that are partially spun and show red serum.Customer confirms that end-user states: · tubes sit for 30 minutes before centrifugation, tubes are spun no later than 2 hours after collection, tubes are properly filled to ±10% of the stated blood volume.The centrifugation is 3,380 rpm, 1600 rcf for 15 minutes - default settings for the machine at the client's office.

Manufacturer Narrative

Received 1pc 455071p/b20043qg.Received customer pictures.We have no further inventory of the material/batch.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 error.Sample was tested, according to gbo standard testing procedures, with regards to correct assembly, level mark, filling level, draw volume and additive 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'.Tube was 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 sample.The tube tested filled within the +/-10% tolerance range.Additive content was found to be within specification in the tested sample.No deviations could be duplicated.Corrected data: h3: sample received; h6: investigation method, investigation findings, investigation conclusion; h10 manufacturer narrative.

• Brand Name: VACUETTE TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 11013930
• MDR Text Key: 226641948
• Report Number: 1125230-2020-00075
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Device Lot Number: B20043QG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1