MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE 3 ML VIRUS STABILIZATION TUBE 13X100 RED CAP-WHITE RING, PREMIUM; CULTURE MEDIA

Model Number 456161

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).A date of the event could not be obtained from the customer.No samples were received.The provided photos were forwarded to the manufacturer, where we purchase they product from.As soon as the investigation of the alleged event is completed, a supplemental report will be filed.

Event Description

Customer states 8 tubes do not have pbs in them.They have not observed pbs leaking, so they believe they were never filled.Customer advises that the provided photos of these tubes had swabs added to the tubes before the discovery was made that no liquid was in them, so they cannot remove them from the bsl-2+ and therefore can not return tubes.They will watch for more empty tubes and send those if discovered.Unfortunately, it wasn't caught during the kit making process and was only caught after they came back post sampling.No liquid was found in the bags that were used to house the tubes and the swabs were completely dry.No observable liquid was found in the tubes or in the bag indicating that the tubes had no liquid in them.Customer advises there is no way to know at this time if the tubes were from the same rack or multiple racks.Customer advises the carton and rack label are now long gone.

Manufacturer Narrative

Received customer pictures.We have no further complaints on the material/batch.We have no further inventory of the material/batch.We forwarded the complaint and customer pictures to our affiliated headquarters in austria from which we receive this product.According to their investigation and comments, an intensive root cause analysis was conducted; however, a root cause for the reported claim could not be found.Currently, there are no complaints on the reported mishap.The complaint cannot be determined.Corrected data: h6: type of investigation, investigation conclusion; h10: manufacturer narrative.

• Brand Name: VACUETTE 3 ML VIRUS STABILIZATION TUBE 13X100 RED CAP-WHITE RING, PREMIUM
• Type of Device: CULTURE MEDIA
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller str. 32; kremsmuenster, upper austria 4550 ; AU 4550
• MDR Report Key: 11368740
• MDR Text Key: 258297052
• Report Number: 8020040-2021-00011
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 456161
• Device Catalogue Number: 456161
• Device Lot Number: A200835H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1