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 SOLN PINT BTL 02.0031 manufactured by Mesa Laboratories.
[4153989]
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 9/30/2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3607962 |
| MDR Report Key | 3607962 |
| Date Received | 2014-01-24 |
| Date of Report | 2013-10-02 |
| Date of Event | 2013-09-30 |
| Date Added to Maude | 2014-02-06 |
| 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 SOLN PINT BTL |
| 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 Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MESA LABORATORIES |
| Brand Name | MESA LABORATORIES PH 7.0 BUFFER SOLN QUART BTL |
| 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 |