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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 32 bad haller strasse; kremsmuenster, austria 4550 ; AU 4550
• MDR Report Key: 9742376
• Report Number: 8020040-2018-00010
• Device Sequence Number: 13903758
• Product Code: JKA
• UDI-Device Identifier: 29120017571708
• UDI-Public: 29120017571708
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention