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 02.0031 manufactured by Mesa Laboratories.
[20357026]
We have learned of a potential mold contamination of (b)(4) 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 (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
| Report Number | 3607900 |
| MDR Report Key | 3607900 |
| 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 |
| Brand Name | MESA LABORATORIES PH 7.0 BUFFER SOLUTION |
| Generic Name | NONE |
| Product Code | JCC |
| Date Received | 2014-01-24 |
| Catalog Number | 02.0031 |
| Lot Number | ML-P7-1164 |
| Device Expiration Date | 2015-01-19 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MESA LABORATORIES |
| Brand Name | MESA LABORATORIES PH 7.0 BUFFER SOLUTION |
| Generic Name | NONE |
| Product Code | JCC |
| Date Received | 2014-01-24 |
| Catalog Number | 02.0030 |
| Lot Number | ML-P7-1164 |
| Device Expiration Date | 2015-01-19 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MESA LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-24 |