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

Catalog Number 02.0030

Device Problems Device Contamination With Biological Material (2908); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/22/2013

Event Type  malfunction  

Event Description

It was discovered there was potential mold growth of mesa laboratories 7.0 ph buffer solution used in this facility.Five bottles of product showed particles and/or visible growth.No patient issues have been identified at this time.

• Brand Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION QUART
• Type of Device: MESA LABORATORIES 7.0 PH BUFFER SOLUTION QUART
• Manufacturer (Section D): MESA LABORATORIES
• MDR Report Key: 3651270
• MDR Text Key: 16082585
• Report Number: 3651270
• 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: 10/01/2013
• 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: 09/14/2014
• Device Catalogue Number: 02.0030
• Device Lot Number: ML-P7-1122
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other