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

Catalog Number PART # 02.0031

Device Problem Fungus in Device Environment (2316)

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

Event Date 09/30/2013

Event Type  malfunction  

Event Description

We have learned of potential mold contamination of (b)(4) laboratories 7.0 ph buffer solution that is used at this facility.At this tine we are not aware of any adverse events associated with this problem, however, we want to alert (b)(4) mesa laboratories and the fda to the issue.

• Brand Name: MESA LABORATORIES PH 7.0 BUFFER SOLUTION PINT
• Type of Device: MESA LABORATORIES PH 7.0 BUFFER SOLUTION PINT
• Manufacturer (Section D): MESA LABORATORIES
• MDR Report Key: 3608800
• MDR Text Key: 19804194
• Report Number: 3608800
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/23/2014
• Device Catalogue Number: PART # 02.0031
• Device Lot Number: ML-P7-1122
• 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