MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for ULTRA BAG DIANEAL LOW 5B9778P manufactured by Baxter Healthcare Corp..
[128594640]
The bags serum ultra bag came broken in the lines of drainage, my husband is pt of dialysis, and found 7 bags broken and liquid. I have photos and video of that finding. Notify to the company baxter, still i have the supplies. Talk with (b)(4), "is the number of complaint is (b)(4). Still, i have and nobody has picked up. The feel use the translator my language is spanish. " thanks. Dr (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081622 |
| MDR Report Key | 8106256 |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-22 |
| Date of Event | 2018-11-08 |
| Date Added to Maude | 2018-11-27 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | ULTRA BAG |
| Generic Name | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES |
| Product Code | MON |
| Date Received | 2018-11-26 |
| Model Number | DIANEAL LOW |
| Catalog Number | 5B9778P |
| Lot Number | Y261865 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 32650 N. WILSON RD WGL - 3N ROUND LAKE IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-11-26 |