MAUDE Adverse Event Report: MESA LABORATORIES MESA LABORATORIES 7.0 PH BUFFER SOLUTION, PINT

Catalog Number 02.0030

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 10/03/2013

Event Type  malfunction  

Event Description

Received notification of potential mold growth in identified mesa lot numbers.Facility stock was evaluated and affected lot numbers identified and removed from facility inventory.No known adverse event from this product has occurred at this time.

• Brand Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION, PINT
• Type of Device: MESA LABORATORIES 7.0 PH BUFFER SOLUTION, PINT
• Manufacturer (Section D): MESA LABORATORIES
• MDR Report Key: 3651271
• MDR Text Key: 4318352
• Report Number: 3651271
• 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: 10/09/2013
• 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: 07/07/2014
• Device Catalogue Number: 02.0030
• Device Lot Number: ML-P7-1138
• 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