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

Model Number 456087P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).We have no further inventory of the material/batch.We have no further complaints on the material/batch.Customer provided photos and samples for further evaluation.Device evaluation is anticipated but not yet but not yet begin, supplement report will be filed upon completion of investigation.

Event Description

Customer states increased hemolysis with the green top tube.

Event Description

Customer states increased hemolysis with the green top tube.

Manufacturer Narrative

Complaint statement (b)(4): received 1rk 456087p/b20083by for evaluation.Received customer picture.We have no further inventory of the material/batch.We have no further complaints on the material/batch.A review of quality, production, and maintenance documents shows no deviations in relation to the reported issue.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 guide line 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 samples.Complaint could not be duplicated.

• Brand Name: VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RINGED
• Type of Device: EVACUATED BLOOD COLLECTION TUBES
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 10763416
• MDR Text Key: 229565346
• Report Number: 1125230-2020-00038
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 456087P
• Device Catalogue Number: 456087P
• Device Lot Number: B20083BY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1