MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE® TUBE 4 ML K3E K3EDTA 13X75 LAVENDER CAP-BLACK RING, PREMIUM; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 454036

Device Problem Suction Problem (2170)

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

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

Complaint number: (b)(4).Testing of retained samples as well as check of manufacturing documents at the supplier did not show any deviations.In addition the reported error could not be confirmed during internal testing of the samples provided by the customer.Therefore, it is assumed that the reported problem was not caused by an error of the above mentioned products.Due to the fact that the reported problem could not be linked to an error of above mentioned products, no actions are necessary from the manufacturers point of view.Nevertheless, the reported problem will be observed on the market.

Event Description

As informed by (b)(6), customer "(b)(6) hospital association" completed an mdr on february 12, 2018.Reason for the mdr was lack of vacuum and as a result blood collection tubes weren't filled completely.On friday (b)(6) 2018, greiner bio-one received information from (b)(6).Customer ( (b)(6)) was immediately contacted on monday (b)(6) 2018 and according to customer's information, safety of patient, user or third were not negatively influenced.The event did not require medical or surgical intervention.Customer did not send an official complaint to greiner bio-one on the date that the information was received from (b)(6).

• Brand Name: VACUETTE® TUBE 4 ML K3E K3EDTA 13X75 LAVENDER CAP-BLACK RING, PREMIUM
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 32 bad haller strasse; kremsmuenster, austria 4550 ; AU 4550
• 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: 9742376
• MDR Text Key: 195095179
• Report Number: 8020040-2018-00010
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 29120017571708
• UDI-Public: 29120017571708
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2019
• Device Model Number: 454036
• Device Catalogue Number: 454036
• Device Lot Number: C170937K
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention