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

Catalog Number 02.0031

Device Problem Device Contamination With Biological Material (2908)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2013

Event Type  malfunction  

Event Description

Rec'd notification of potential mold growth in the identified lot numbers from (b)(4).Affected lot numbers identified and removed from the facility stock.No pt adverse events have occurred as a result of this product.

• Brand Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION
• Type of Device: NONE
• Manufacturer (Section D): MESA LABORATORIES
• MDR Report Key: 3653234
• MDR Text Key: 4201876
• Report Number: 3653234
• 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: 10/08/2013
• 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: 02/23/2014
• Device Catalogue Number: 02.0031
• Device Lot Number: ML-P7-1122
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other