MAUDE Adverse Event Report: VALITEQ TRYPTIC SOY AGAR; CONTACT PLATES

Catalog Number C6045

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2017

Event Type  malfunction  

Event Description

Agar plates (c6045 - tryptic soy agar with lecithin and polysorbate 80) manufactured by valiteq had growth within plates prior to opening.The incubation instructions on the quality certificate and use of contact sampling plates were both incorrect.Quality certificate current incubation states: minimum incubation time of 5 days at 20-25c and 33-37c.Use of contact sampling plates states: incubate at 20-25 c for a period of 2 weeks.Check plates for microbial development at 24 hours, 48 hours, 96 hours, one week and 2 weeks.Per valiteq the correct incubation is at 20-25 c for a period of 2 weeks, check plates for microbial development at 24 hours, 48 hours, 72 hours, 1 week and 2 weeks.Diagnosis or reason for use: environmental sampling.

• Brand Name: TRYPTIC SOY AGAR
• Type of Device: CONTACT PLATES
• Manufacturer (Section D): VALITEQ; cumberland WI 54829
• MDR Report Key: 6604316
• MDR Text Key: 76536762
• Report Number: MW5070096
• Device Sequence Number: 1
• Product Code: JSG
• 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: 05/18/2017

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: 07/12/2017
• Device Catalogue Number: C6045
• Device Lot Number: 1005484570
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1