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.
[180853308]
Angiodynamics power port placed on (b)(6) 2019. Pt came for blood draw today and this is the 3rd time in a row pt had difficulty getting blood for labs from port. Requires several flushes and pt in supine position with left arm elevated. Blood return for lab was finally attained. Port placed (b)(6) 2019 w/o problems. Cxr shows tip svc/ra jct. The 'ct' stamp on port to indicate pressure injection is barely visible, could see when i used magnifier in epic imaging. Very unusual to have problems with blood return / lab collection and ns flush. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093174 |
| MDR Report Key | 9739679 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-11 |
| 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 | 5528062 |
| 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 |