MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for TRYPTIC SOY AGAR C6045 manufactured by Valiteq.
[76536762]
Agar plates (c6045 - tryptic soy agar with lecithin and polysorbate 80) manufactured by valiteq had growth within plates prior to opening. The incubation instructions on the quality certificate and use of contact sampling plates were both incorrect. Quality certificate current incubation states: minimum incubation time of 5 days at 20-25c and 33-37c. Use of contact sampling plates states: incubate at 20-25 c for a period of 2 weeks. Check plates for microbial development at 24 hours, 48 hours, 96 hours, one week and 2 weeks. Per valiteq the correct incubation is at 20-25 c for a period of 2 weeks, check plates for microbial development at 24 hours, 48 hours, 72 hours, 1 week and 2 weeks. Diagnosis or reason for use: environmental sampling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070096 |
| MDR Report Key | 6604316 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-05-03 |
| Date Added to Maude | 2017-06-01 |
| 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 | PHARMACIST |
| 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 | TRYPTIC SOY AGAR |
| Generic Name | CONTACT PLATES |
| Product Code | JSG |
| Date Received | 2017-05-18 |
| Catalog Number | C6045 |
| Lot Number | 1005484570 |
| Device Expiration Date | 2017-07-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALITEQ |
| Manufacturer Address | CUMBERLAND WI 54829 US 54829 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-18 |