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

Catalog Number 02.0031

Device Problem Nonstandard Device (1420)

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

Event Date 10/01/2013

Event Type  malfunction  

Event Description

We have learned of a recall on (b)(6) 7.0 ph buffer solution.The bottles were identified and pulled from stock.At this time, we are not aware of any adverse event related to this product.

• Brand Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION
• Type of Device: NONE
• Manufacturer (Section D): MESA LABORATORIES
• MDR Report Key: 3653240
• MDR Text Key: 4201879
• Report Number: 3653240
• 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: 10/01/2013
• 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: 12/07/2014
• Device Catalogue Number: 02.0031
• Device Lot Number: ML-P7-1158
• 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