MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-15 for SHEEP BLOOD AGAR, STRENGTH 5 PERCENT manufactured by Remel.
[75403269]
Two different lots of sheep blood agar over three different shipments contaminated with different types of mold growth. Product description: remel 5 percent blood agar product code r01202. Affected lot numbers 140587 and 137952. Sheep blood agar is general media for microbiology culture growth on patient specimens. This directly affects patient care and safety. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Diagnosis or reason for use: general microbiology media.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069801 |
| MDR Report Key | 6568719 |
| Date Received | 2017-05-15 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-05-09 |
| Date Added to Maude | 2017-05-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHEEP BLOOD AGAR, STRENGTH 5 PERCENT |
| Generic Name | SHEEP BLOOD AGAR, STRENGTH 5 PERCENT |
| Product Code | JSH |
| Date Received | 2017-05-15 |
| Lot Number | 140587 |
| Device Expiration Date | 2017-06-28 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REMEL |
| Brand Name | SHEEP BLOOD AGAR, STRENGTH 5 PERCENT |
| Generic Name | SHEEP BLOOD AGAR, STRENGTH 5 PERCENT |
| Product Code | JSH |
| Date Received | 2017-05-15 |
| Lot Number | 137952 |
| Device Expiration Date | 2017-06-28 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | REMEL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-15 |