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

Model Number 454209

Device Problem Obstruction of Flow (2423)

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

Event Type  malfunction  

Event Description

Customer called to inquire if there had been reports of clotted edta specimens.Customer identified his site and location as well as the item and lot number to which they experienced the clotting.Customer advised that unused tubes he had seen seem to have an uneven pattern of edta sprayed on the tube wall where half of the wall seemed to have no edta.Customer added that some unused tubes have the edta clumped at the tube bottom and no edta on the wall.Customer stated that clotted specimens were fully clotted.Customer believed the site has 12-14 racks and would try to have photograph arranged.

Manufacturer Narrative

Complaint statement (b)(4): no samples were received for evaluation.No customer pictures were received.Customer called and advised that increased inversions of tubes corrected the issue, and they are no longer experiencing clotted specimens.The alleged event seems to relate to the usage.

• Brand Name: VACUETTE® TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED
• Type of Device: EVACUATED BLOOD COLLECTION 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: 15640619
• MDR Text Key: 302429409
• Report Number: 1125230-2022-00043
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1