MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT BTL 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 PH 7.0 BUFFER SOLUTION PT BTL 02.0031 manufactured by Mesa Laboratories.

Event Text Entries

[19763312] We have learned of a potential mold contamination of mesa 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 mesa laboratories and the fda of this issue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3621960
• MDR Report Key: 3621960
• Date Received: 2014-01-24
• Date of Report: 2013-10-09
• Date of Event: 2013-09-28
• Date Added to Maude: 2014-02-12
• 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 PH 7.0 BUFFER SOLUTION PT BTL
• Generic Name: NONE
• Product Code: JCC
• Date Received: 2014-01-24
• Catalog Number: 02.0031
• Lot Number: ML-P7-1138
• Device Expiration Date: 2014-07-04
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MESA LABORATORIES

Device Sequence Number: 2

• Brand Name: MESA LABORATORIES PH 7.0 BUFFER SOLUTION QRT BTL
• Generic Name: NONE
• Product Code: JCC
• Date Received: 2014-01-24
• Catalog Number: 02.0030
• Lot Number: ML-P7-1158
• Device Expiration Date: 2014-12-07
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MESA LABORATORIES

Patients

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