MAUDE Adverse Event Report: GREINER BBIO-ONE NA INC VACUETTE 2ML K2E K2EDTA TUBES 13X75; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 454428

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint (b)(4).Received 20 loose pisces of 434428/b14103ad for evaluation.No samples for other material/batch were received.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.No deviation could be observed on the samples.We have no further inventory of the material/batches.We have no further complaints on the material/batches.A check of quality records shows no deviations related to the reported events.The complaint cannot be confirmed.

Event Description

Customer states that they are having issues with low vacuum.

• Brand Name: VACUETTE 2ML K2E K2EDTA TUBES 13X75
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BBIO-ONE NA INC; 4238 capital drive; monroe, nc
• Manufacturer (Section G): GREINER BIO-ONE NA INC; 4238 capital drive; monroe, nc
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, nc ; 2617823
• MDR Report Key: 10422865
• MDR Text Key: 204557834
• Report Number: 1125230-2015-00004
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK030032
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 454428
• Device Catalogue Number: 454428
• Device Lot Number: B140737R, B14103AD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• 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