MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-05-06 for EFFLUENT BAG 107650 manufactured by Baxter Healthcare - Medolla Modena Blood.
[144159971]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[144159972]
It was reported that a 9l effluent drain bag leaked from the top fold of the bag during? Filling?. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610270-2019-00004 |
| MDR Report Key | 8582343 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-05-06 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-03-23 |
| Date Facility Aware | 2019-04-10 |
| Report Date | 2019-05-06 |
| Date Reported to FDA | 2019-05-06 |
| Date Reported to Mfgr | 2019-05-06 |
| Date Mfgr Received | 2019-06-06 |
| Date Added to Maude | 2019-05-06 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 - MEDOLLA MODENA BLOOD |
| Manufacturer Street | VIA MODENESE, 66 |
| Manufacturer City | MEDOLLA MODENA 41036 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41036 |
| 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 | 2019-05-06 |
| Returned To Mfg | 2019-06-04 |
| Model Number | NA |
| Catalog Number | 107650 |
| Lot Number | 1841 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - MEDOLLA MODENA BLOOD |
| Manufacturer Address | MEDOLLA MODENA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-06 |