MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for HEPARIN SYRINGE manufactured by Becton Dickinson And Company.
[110337160]
Serratia marcescens bacteremia. Pt had central vascular access catheter that was being maintained with heparin. Product used for maintaining line included bd heparin syringe that was part of a voluntary recall for serratia marcescens. Dose or amount: 5 ml millilitre(s), daily, intravenous. Therapy start date: (b)(6) 2018; therapy end date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077643 |
| MDR Report Key | 7572915 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-05-05 |
| Date Added to Maude | 2018-06-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEPARIN SYRINGE |
| Generic Name | HEPARIN, VASCULAR ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2018-06-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Manufacturer Address | COLUMBUS NE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-05 |