MAUDE Adverse Event Report: MESA LABORATORIES MESA LABORATORIES PH 7.0 BUFFER SOLUTION QUART BTL; NONE

Catalog Number 02.0030

Device Problem Device Contamination With Biological Material (2908)

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

Event Date 10/02/2013

Event Type  malfunction  

Event Description

We have learned of a potential mold contamination of (b)(6) 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 (b)(6) laboratories and the fda the issue.Product use was discontinued upon notice of the possible mold issue on or around (b)(6) 2013.

• Brand Name: MESA LABORATORIES PH 7.0 BUFFER SOLUTION QUART BTL
• Type of Device: NONE
• Manufacturer (Section D): MESA LABORATORIES
• MDR Report Key: 3622061
• MDR Text Key: 4134124
• Report Number: 3622061
• 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: 10/03/2013
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/17/2014
• Device Catalogue Number: 02.0030
• Device Lot Number: ML-P7-1128
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other