MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED; BLOOD COLLECTION TUBES

Model Number 454209

Device Problems Improper or Incorrect Procedure or Method (2017); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

No samples were received for evaluation.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.The complaint cannot be determined.

Event Description

Customer states several clients have called concerned that the blood they sent in the lavender tube ended up clotted when received in lab.This is highly unusual from these offices, who are proficient in drawing blood.Technical services requested additional information regarding complaint of clotting.Customer stated she is doubtful that it is a lot issue once their technical team got back to them [user error].The one tube was a short draw and the 2nd [tube] couldn't examine since it had been discarded.Customer advises they are monitoring.Not returning product, and no photos.No further information available.

• Brand Name: VACUETTE TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED
• Type of Device: BLOOD COLLECTION TUBES
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monoroe 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 ; 7042617800
• MDR Report Key: 10816789
• MDR Text Key: 218590605
• Report Number: 1125230-2020-00046
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 454209
• Device Catalogue Number: 454209
• Device Lot Number: B200739G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1