MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 4ML K2E K2EDTA NR LIL/S 13X75; EVACUATED BLOOD COLLECTION TUBE

Model Number 454209

Device Problems Fluid/Blood Leak (1250); Short Fill (1575); Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Received 50pc 454209/b180435m for evaluation.Received customer pictures.The actual sample (seen in customer pictures) was not received.We have no further inventory of the material/batch.A check of quality, production and maintenance records shows no deviations related to the reported issue.Samples were tested, according to gbo standard testing procedures, with regards to correct assembly, level mark, filling level, draw volume 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.No short fills could be observed on the samples.No deviations with the cap assembly could be observed prior to, during or after filling of the tubes.All components (cap bodies, rubber stoppers and ring plates) were intact and remained intact.The complaint could not be confirmed.

Event Description

Customer states that tubes are underfilling.Customer also states when removing a tube from the holder, the rubber stopper and ring come out and get stuck in the holder, resulting in blood leakage.

• Brand Name: VACUETTE 4ML K2E K2EDTA NR LIL/S 13X75
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer (Section G): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: renee neuenkirk ; 60 e court ave; winterset, IA 50273 ; 5154621162
• MDR Report Key: 10770948
• MDR Text Key: 228230751
• Report Number: 1125230-2018-00010
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Model Number: 454209
• Device Catalogue Number: 454209
• Device Lot Number: B180435M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1