MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for SMART PORT H787CT80STPDV11 manufactured by Angiodynamics.
[180826795]
Ongoing difficulty obtaining blood return on smart port inserted (b)(6) 2020. At daily appts (b)(6) and again at appt on (b)(6) 2020 difficulty obtaining blood return. Able to obtain blood return each day after saline flushing and pt repositioning multiple times. Unable to obtain consistent blood return for lab draw on (b)(6) 2020 until after iv infusion. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093173 |
| MDR Report Key | 9739664 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-03 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| 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 | SMART PORT |
| Generic Name | PORT AND CATHETER, IMPLANTED SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-02-20 |
| Model Number | H787CT80STPDV11 |
| Lot Number | 5532259 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |