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 2020-01-09 for EFFLUENT BAG 107650 manufactured by Baxter Healthcare Corporation.
[174473112]
The event occurred on an unknown date. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174473113]
It was reported that during treatment with five sp-418 effluent bags, external fluid leaks were observed. It was reported the bags? Deform during filling? And? Begin? To leak on the weld near the port. 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
[179669289]
An actual sample was received for evaluation. The sample was received in a plastic bag, with no indication to which batch it belongs to. The sample underwent visual inspection by the naked eye and no issues were noted. The sample was then filled with water and left to hang, and it was noted that the bag had a pin hole leak on the seam bag. The reported condition was verified. The cause was undetermined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07479 |
| MDR Report Key | 9569900 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-01-09 |
| 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 - MALTA |
| Manufacturer Street | A47 INDUSTRIAL ESTATE |
| Manufacturer City | MARSA |
| Manufacturer Country | MT |
| 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 | 2020-01-09 |
| Returned To Mfg | 2020-01-15 |
| Model Number | NA |
| Catalog Number | 107650 |
| Lot Number | 19E21V558 |
| 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 CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |