MAUDE Adverse Event Report: MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT

Catalog Number PART # 02.0031

Device Problem Fungus in Device Environment (2316)

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

Event Date 09/21/2013

Event Type  malfunction  

Event Description

We have learned of a potential mold contamination of mesa laboratories 7.0 ph buffer solution that is used at this facility.At this time, we are not aware of any adverse events associated with this problem; however, we want to alert both mesa laboratories and the fda of this issue.

• Brand Name: MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT
• Type of Device: MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT
• MDR Report Key: 3608812
• MDR Text Key: 16801662
• Report Number: 3608812
• Device Sequence Number: 1
• Product Code: JCC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2013
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PART # 02.0031
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other