MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-24 for BD PORT-A-CUL 221607 manufactured by Becton Dickinson And Company.
[2857635]
Pt was in for surgery for right shoulder fracture. Gram stain of 2 surgical specimens showed rare gram negative rods. One culture grew (b)(6) and the other was negative. Pt was treated for (b)(6) rather than gram negative rods as pt had a prosthetic device. Date of use: since before 1980.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026281 |
| MDR Report Key | 2675686 |
| Date Received | 2012-07-24 |
| Date of Report | 2012-07-24 |
| Date of Event | 2012-05-30 |
| Date Added to Maude | 2012-08-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BD PORT-A-CUL |
| Generic Name | ANAEROHIC SPECIMEN COLLECTION AND TRANSPORT |
| Product Code | JTX |
| Date Received | 2012-07-24 |
| Catalog Number | 221607 |
| Lot Number | 1332996 |
| Device Expiration Date | 2012-11-22 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-24 |