MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-08 for TSB GOWTH MEDIA 100 ML FROM QT2000 KIT TSB GROWTH MEDIA 100 ML manufactured by Qi Medical.
[33490073]
Prior to end-product testing using the qt2000 by qi medical, the tsb growth media 100 ml bag, lot 1518701 exp 07/2017, was found to have a red/brown particle in the luer lock area of the port. This was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058476 |
| MDR Report Key | 5294122 |
| Date Received | 2015-12-08 |
| Date of Report | 2015-12-08 |
| Date of Event | 2015-12-03 |
| Date Added to Maude | 2015-12-14 |
| 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 | TSB GOWTH MEDIA 100 ML FROM QT2000 KIT |
| Generic Name | TSB GROWTH MEDIA 100 ML FROM QT2000 KIT |
| Product Code | JSC |
| Date Received | 2015-12-08 |
| Model Number | TSB GROWTH MEDIA 100 ML |
| Catalog Number | QT2000 |
| Lot Number | 1518701 |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QI MEDICAL |
| Manufacturer Address | GRASS VALLEY CA 95945 US 95945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-08 |