MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE TUBE 3 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED; EVACUATED BLOOD COLLECTION TUBE

Model Number 454246

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Exact dates of the described events could not be obtained from the customer.Samples from the customer were just recently received and the evaluation of samples as well as investigation of the described issue is still in process.As soon as the investigation is completed a supplemental report will be filed.

Event Description

Customer states there have been an increased number clotted samples; almost double from last year same time.Number of occurrences: (b)(6) 2020 - 59 clotted; (b)(6) 2021 - 103 clotted, (b)(6) 2020 - 61 clotted; (b)(6) 2021 - 94 clotted.Customer states multiple lots and is reporting the one in current use.

Manufacturer Narrative

No samples were received for evaluation.We have no further complaints on this material/batch.A review of quality, production, and maintenance documents shows no deviations in relation to the reported issue.The complaint cannot be determined.

• Brand Name: VACUETTE TUBE 3 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 12210920
• MDR Text Key: 265158059
• Report Number: 1125230-2021-00059
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K971236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Model Number: 454246
• Device Catalogue Number: 454246
• Device Lot Number: B21043RH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1