MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-20 for TSB GROWTH MEDIA manufactured by Q.i. Medical, Inc.
[3173386]
It was discovered that a soy broth growth media used to assess sterility of iv preparations was already contaminated with bacteria before any iv product was introduced into the growth media. This is a problem that prevents the pharmacy from being able to accurately determine if iv preparations are sterile or contaminated. The product is tsb growth media 100ml - lot#1129001; exp: oct 13, manufactured by (b)(4). Dates of use: (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029224 |
| MDR Report Key | 2993981 |
| Date Received | 2013-02-20 |
| Date of Report | 2013-02-20 |
| Date of Event | 2013-02-19 |
| Date Added to Maude | 2013-03-11 |
| 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 | PARAMEDIC |
| 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 | TSB GROWTH MEDIA |
| Generic Name | TSB GROWTH MEDIA |
| Product Code | JSC |
| Date Received | 2013-02-20 |
| Lot Number | 1129001 |
| Device Expiration Date | 2013-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | Q.I. MEDICAL, INC |
| Manufacturer Address | NEVADA CITY CA 95959 US 95959 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-20 |