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

Model Number TSB GROWTH MEDIA 100 ML

Device Problems 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.

• Brand Name: TSB GOWTH MEDIA 100 ML FROM QT2000 KIT
• Type of Device: TSB GROWTH MEDIA 100 ML FROM QT2000 KIT
• Manufacturer (Section D): QI MEDICAL; grass valley CA 95945
• MDR Report Key: 5294122
• MDR Text Key: 33490073
• Report Number: MW5058476
• Device Sequence Number: 1
• Product Code: JSC
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: TSB GROWTH MEDIA 100 ML
• Device Catalogue Number: QT2000
• Device Lot Number: 1518701
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1