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.
[180857283]
Unable to obtain blood return on smart port inserted (b)(6) 2020. At port lab draw appt on (b)(6) 2020 unable to obtain blood return and port flushes with difficulty even with repositioning pt multiple times. Pt reported that nurses had been having problems at prior appts obtaining blood return. Port re-accessed with another huber needle - still only able to obtain flash of blood return following saline and heparin flushes and repositioning pt. Pt had to have peripheral draw for lab work. All appt on (b)(6) 2020, no blood return obtained even after flushing and repositioning pt. Cathflo had to be instilled in port before able to obtain blood return and proceed with treatment as planned. Unusual for cathflo to be needed on a port so soon after insertion. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093172 |
| MDR Report Key | 9739645 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-07 |
| 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 | 5530081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |