MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-28 for PORT-A-CUL & SWABS STERILE PACE manufactured by Becton Dickinson Microbiology Systems.
[20438763]
Specimen collection medium in some tubes have started to change color. Viability of microorganisms during transportation from the pt to the lab cannot be guaranteed. Cannot be used in maintaining viability of microorganisms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000988 |
| MDR Report Key | 29094 |
| Date Received | 1995-12-28 |
| Date of Report | 1995-08-22 |
| Date Added to Maude | 1995-12-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORT-A-CUL & SWABS STERILE PACE |
| Generic Name | CULTURE MEDIA |
| Product Code | JSC |
| Date Received | 1995-12-28 |
| ID Number | TD50259Z |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30108 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | COOKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-28 |