MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for PALL SUPOR? 1.2 FILTER AEF2NT manufactured by Pall Corporation.
[180749145]
Filter keeps backing up in the iv infusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9750228 |
| MDR Report Key | 9750228 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-02 |
| Report Date | 2020-01-09 |
| Date Reported to FDA | 2020-01-09 |
| Date Reported to Mfgr | 2020-02-25 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | PALL SUPOR? 1.2 FILTER |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2020-02-25 |
| Model Number | AEF2NT |
| Catalog Number | AEF2NT |
| Lot Number | 13384809 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALL CORPORATION |
| Manufacturer Address | 25 HARBOR PARK DR PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |