MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-28 for EFFLUENT BAG 114423 manufactured by Baxter Healthcare - Brooklyn Park.
[101468698]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[101468699]
The customer observed a leakage from the connection port of a 5l effluent drain bag during use. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003504604-2018-00002 |
| MDR Report Key | 7303982 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-28 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - BROOKLYN PARK |
| Manufacturer Street | 7601 NORTHLAND DRIVE N SUITE 170 |
| Manufacturer City | MINNEAPOLIS MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EFFLUENT BAG |
| Generic Name | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES |
| Product Code | MON |
| Date Received | 2018-02-28 |
| Model Number | NA |
| Catalog Number | 114423 |
| Lot Number | A3152 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - BROOKLYN PARK |
| Manufacturer Address | MINNEAPOLIS MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |