MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-09 for DRUG BAG manufactured by Nxstage Medical Inc..
[105244381]
White caps on nxstage bags are falling off. Nxstage rfp 406, lot q1801344, exp 2020-01-01. Nx stage rfp 404, lot f1712381, exp 2019-12-01. Device #2 therapy start date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076384 |
| MDR Report Key | 7411295 |
| Date Received | 2018-04-09 |
| Date of Event | 2018-04-05 |
| Date Added to Maude | 2018-04-10 |
| 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 | DRUG BAG |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2018-04-09 |
| Lot Number | Q1801344 |
| Device Expiration Date | 2020-01-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL INC. |
| Brand Name | DRUG BAG |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2018-04-09 |
| Lot Number | F1712381 |
| Device Expiration Date | 2019-12-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-09 |