MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-03 for THIOGLYCOLLATE VITAMIN K AND HEMIN * manufactured by Becton Dickinson.
[1022372]
Gram stain results yielded gram positive beaded organisms on multiple specimens which were grounded using thioglycollate. No organisms were seen when the same specimens were tested again without using thioglycollate. The media was found to have high counts of nonviable organisms. ====================== manufacturer response for microbiology culture media, thioglycollate vitamin k and hemin======================the response was that a gram stain by itself can neither rule in or out infection since artifacts and non-viables may be present in the transport media. Most liquid media will have some level of microorganisms present in the product. The batch history record was reviewed and was found to be satisfactory. There was no evidence of contamination in the retention sample. There was no evidence of contamination in the return sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1280623 |
| MDR Report Key | 1280623 |
| Date Received | 2008-12-03 |
| Date of Report | 2008-11-10 |
| Date of Event | 2008-11-03 |
| Report Date | 2008-11-10 |
| Date Reported to FDA | 2008-12-03 |
| Date Added to Maude | 2009-01-08 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THIOGLYCOLLATE VITAMIN K AND HEMIN |
| Generic Name | MICROBIOLOGY CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 2008-12-03 |
| Returned To Mfg | 2008-11-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 8164953 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE; MC2266 FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-03 |