MESA LABORATORIES PH7.0 BUFFER SOLN PINT AND QUART BTL PART # 02.0031

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-24 for MESA LABORATORIES PH7.0 BUFFER SOLN PINT AND QUART BTL PART # 02.0031 manufactured by Mesa Laboratories.

Event Text Entries

[4090391] We have learned of a potential mold contamination of (b)(4) laboratories 7. 9 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)(4) laboratories and the fda to the issue. Product use was discontinued upon notice of the possible mold issue on or around 09/30/2013.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3608821
• MDR Report Key: 3608821
• Date Received: 2014-01-24
• Date of Report: 2013-10-01
• Date of Event: 2013-09-30
• Date Added to Maude: 2014-02-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MESA LABORATORIES PH7.0 BUFFER SOLN PINT AND QUART BTL
• Generic Name: MESA LABORATORIES PH7.0 BUFFER SOLN PINT AND QUART BTL
• Product Code: JCC
• Date Received: 2014-01-24
• Catalog Number: PART # 02.0031
• Lot Number: ML-P7-1164
• Device Expiration Date: 2015-01-19
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MESA LABORATORIES

Device Sequence Number: 2

• Brand Name: MESA LABORATORIES PH7.0 BUFFER SOLN PINT AND QUART BTL
• Generic Name: MESA LABORATORIES PH7.0 BUFFER SOLN PINT AND QUART BTL
• Product Code: JCC
• Date Received: 2014-01-24
• Catalog Number: PART # 02.0030
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MESA LABORATORIES

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-01-24