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, Inc..
[180889639]
Difficulty obtaining blood return on smart port placed (b)(6) 2020. On (b)(6) 2020 only able to obtain minimal blood return after multiple saline flushes and pt repositioned. Had to flush port with heparin 500 units before able to obtain better blood return to proceed with planned treatment. Also noted that the 'ct' that is supposed to be one method for confirming pressure injectable port is not visible on cxr. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093171 |
| MDR Report Key | 9739619 |
| 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 | 5530081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |