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

Model Number 456087P

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Hemolysis (1886)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).We do not have further inventory for this material/batch.We received samples from the same material/lot from the customer for evaluation.A device evaluation is anticipated, but has not yet begun.Upon completion of investigation, a supplemental report will be filed.

Event Description

Customer states they are experiencing hemolysis.This is occurring with collection of blood from iv lines from the emergency department and the number of hemolyzed draws are significant.9 times out of 10 are coming from collecting blood when starting an iv.

Event Description

Customer states they are experiencing hemolysis.This is occurring with collection of blood from iv lines from the emergency department and the number of hemolyzed draws are significant.9 times out of 10 are coming from collecting blood when starting an iv.

Manufacturer Narrative

Gbo complaints (b)(4): received 1rk 456087p/b20083gw for evaluation.Received customer picture.We have no further complaints of the material/batch.We have no further inventory of the material/batch.A check of quality, production, and maintenance records revealed no deviations in relation 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 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 RING
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 10729474
• MDR Text Key: 215070366
• Report Number: 1125230-2020-00034
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: B20083GW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1