MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE® TUBE 3 ML K3E K3EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED; EVACUATED BLOOD COLLECTIO TUBES

Model Number 454217

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).A date of the event could not be obtained.Samples were recently received from the customer, but are no yet evaluated.As soon as the investigation of the event is completed, a supplemental report will be submitted.

Event Description

Customer states: gold tubes -not always clotting completely; blue tubes -not always filling properly; lavender tubes-bubbles causing aspiration errors on dxh 600s.Literature provided and more information requested.In an update, the customer states that they see often that the item 454217 k2 edta showed clotting, clumping, and excessive bubbles.

Manufacturer Narrative

Receive 1rkn 454217/b201138u for evaluation.We have no further complaints on 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 to the reported event.Samples were tested, according to gbo standard testing procedures, with regards to correct assembly, l 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.Therefore, the event is not confirmed.Corrected data: h3: received samples; h6: type ov investigation, investigation findings, investigation conclusion; h10 manufacturer narrative.

• Brand Name: VACUETTE® TUBE 3 ML K3E K3EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED
• Type of Device: EVACUATED BLOOD COLLECTIO TUBES
• 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: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617823
• MDR Report Key: 12857097
• MDR Text Key: 282277654
• Report Number: 1125230-2021-00081
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042927
• 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,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 454217
• Device Catalogue Number: 454217
• Device Lot Number: B201138U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• 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