MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for PRE-FILLED HEPARIN FLUSH SYRINGE manufactured by Bd.
[108693454]
Pt stated within two weeks of using saline solution, she developed an infection. Pt reported watery bloody returns. Towards the end of (b)(6) 2017 the site of picc line was red and swollen. Picc line was taken out (b)(6) 2017. Pt had to take 10 days of antibiotic after picc line removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077276 |
| MDR Report Key | 7525304 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-17 |
| Date of Event | 2017-11-20 |
| Date Added to Maude | 2018-05-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | PRE-FILLED HEPARIN FLUSH SYRINGE |
| Generic Name | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
| Product Code | NZW |
| Date Received | 2018-05-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-17 |