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 2020-02-04 for ALL-IN-ONE CONTAINER ARB8124P manufactured by Baxter Healthcare Corporation.
[177668461]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177668462]
It was reported that an all-in-one container was leaking from the back of the bag. This was identified during setup and prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-00412 |
| MDR Report Key | 9667448 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-04 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-11-16 |
| Date Added to Maude | 2020-02-04 |
| 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 | PHARMACIST |
| 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 - CALI |
| Manufacturer Street | CALLE 36 NO. 2C-22 APARTADO AERO 2446 |
| Manufacturer City | CALI |
| Manufacturer Country | CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-IN-ONE CONTAINER |
| Generic Name | CONTAINER, I.V. |
| Product Code | KPE |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2020-01-16 |
| Model Number | NA |
| Catalog Number | ARB8124P |
| Lot Number | SE19KF9 |
| 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 | 2020-02-04 |