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

MAUDE Adverse Event Report: QI MEDICAL TSB GOWTH MEDIA 100 ML FROM QT2000 KIT TSB GROWTH MEDIA 100 ML FROM QT2000 KIT

  • 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
 

QI MEDICAL TSB GOWTH MEDIA 100 ML FROM QT2000 KIT TSB GROWTH MEDIA 100 ML FROM QT2000 KIT Back to Search Results
Model Number TSB GROWTH MEDIA 100 ML
Device Problems Port (495); Particulates (1451); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2015
Event Type  Malfunction  
Event Description

Prior to end-product testing using the qt2000 by qi medical, the tsb growth media 100 ml bag, lot 1518701 exp 07/2017, was found to have a red/brown particle in the luer lock area of the port. This was not used.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTSB GOWTH MEDIA 100 ML FROM QT2000 KIT
Type of DeviceTSB GROWTH MEDIA 100 ML FROM QT2000 KIT
Manufacturer (Section D)
QI MEDICAL
grass valley CA 95945
MDR Report Key5294122
MDR Text Key33490073
Report NumberMW5058476
Device Sequence Number1
Product Code JSC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 12/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device MODEL NumberTSB GROWTH MEDIA 100 ML
Device Catalogue NumberQT2000
Device LOT Number1518701
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-