MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for NXSTAGE / DIALYSIS BAG manufactured by Nxstage.
[103972399]
White cap is falling off nxstage dialysis bags.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076205 |
| MDR Report Key | 7380875 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-03-26 |
| Date Added to Maude | 2018-03-29 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 0 |
| Brand Name | NXSTAGE / DIALYSIS BAG |
| Generic Name | DIALYSATE |
| Product Code | FKP |
| Date Received | 2018-03-28 |
| Lot Number | Q1801344 |
| Device Expiration Date | 2020-01-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-28 |