MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for BD HEPARIN FLUSH manufactured by Bd.
[108668023]
Pt utilizes a picc line. He had a routine bandage change on (b)(6) at a hospital. On (b)(6), the line was flushed with heparin at his home. On (b)(6) he went to the infusion center due to intense itching where the line was removed. Pt saw his primary care dr who prescribed an oral antibiotic and topical cream. He also experienced bicep discoloration and scaly dry skin and infection. His next pcp appt is on (b)(6) 2018. Situation to date remains unresolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077277 |
| MDR Report Key | 7525305 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-04-05 |
| 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 | BD HEPARIN FLUSH |
| Generic Name | HEPARIN FLUSH |
| Product Code | NZW |
| Date Received | 2018-05-17 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |