MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-08 for BBL PORT-A-CUL 8216020JAA (0903) * manufactured by Becton Dickinson.
[4528994]
The jar was sealed and in still in the package when it was noted that there was a discoloration of the liquid and that there was a floating object in the jar. The jar was not opened. There was no patient harm in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3812009 |
| MDR Report Key | 3812009 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-08 |
| Date of Event | 2014-05-01 |
| Report Date | 2014-05-08 |
| Date Reported to FDA | 2014-05-08 |
| Date Reported to Mfgr | 2014-05-15 |
| Date Added to Maude | 2014-05-15 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | BBL PORT-A-CUL |
| Generic Name | TRANSPORT SYSTEMS, ANAEROBIC |
| Product Code | JTX |
| Date Received | 2014-05-08 |
| Model Number | 8216020JAA (0903) |
| Catalog Number | * |
| Lot Number | 3305487 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417188 US 07417 1884 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-08 |