MAUDE Adverse Event Report: MESA LABORATORIES MESA LABORATORIES PH7.0 BUFFER SOLUTION QUART BTL

Catalog Number PART #02.0030

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/23/2013

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 to the issue.Product use was discontinued upon notice of the possible mold issue on or around (b)(6) 2013.

• Brand Name: MESA LABORATORIES PH7.0 BUFFER SOLUTION QUART BTL
• Type of Device: MESA LABORATORIES PH7.0 BUFFER SOLUTION QUART BTL
• Manufacturer (Section D): MESA LABORATORIES
• MDR Report Key: 3622024
• MDR Text Key: 4133092
• Report Number: 3622024
• Device Sequence Number: 2
• Product Code: JCC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2013
• 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 Expiration Date: 06/17/2014
• Device Catalogue Number: PART #02.0030
• Device Lot Number: ML-P7-1137
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2014
• Patient Sequence Number: 1