• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GREINER BIO-ONE GMBH VACUETTE 3 ML VIRUS STABILIZATION TUBE 13X100 RED CAP-WHITE RING, PREMIUM; CULTURE MEDIA Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11368740
MDR Text Key258297052
Report Number8020040-2021-00011
Device Sequence Number1
Product Code JSG
Combination Product (y/n)N
Number of Events Reported1
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 Date05/01/2021
Device Model Number456161
Device Catalogue Number456161
Device Lot NumberA200835H
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/29/2021
Initial Date FDA Received02/23/2021
Supplement Dates Manufacturer Received01/29/2021
Supplement Dates FDA Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-