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

Model Number 454209

Device Problems Filling Problem (1233); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).A date of the event could not be obtained from the customer.Samples for evaluation were only recently received and results are not yet available.As soon as the investigation is completed a supplemental report will be filed.

Event Description

The customer advised that the edta sprayed in the tubes appears to have a deep, almost orange color which differs from the clear to milky white color they are used to observing the edta appear in the tubes.In addition to the deep to almost orange color, the customer further advised that some tubes appear to have no edta sprayed in them at all.

Manufacturer Narrative

Received 68rk and 90 loose pcs 454209/b220634a for evaluation.Upon visual inspection, no tubes with "deep, almost orange color" edta as described by the customer were observed.This portion of the complaint is not confirmed.During verification of additive content, some tubes were found to contain insufficient amounts of additive.This portion of the product problem is justified - see recall res# 01750.

• Brand Name: VACUETTE® TUBE 4 ML K2E K2EDTA 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: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617823
• MDR Report Key: 15970411
• MDR Text Key: 305793825
• Report Number: 1125230-2022-00054
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 454209
• Device Catalogue Number: 454209
• Device Lot Number: B220634A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES# 91750
• Patient Sequence Number: 1