MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for 0.9% SODIUM CHLORIDE 2B1324 manufactured by Baxter Healthcare Corporation.
[183123629]
1l ns bag on 300mm pressure device spontaneously began to leak at lower portion of iv bag. No harm to patient. Rn changed bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9824037 |
| MDR Report Key | 9824037 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-10 |
| Report Date | 2020-02-17 |
| Date Reported to FDA | 2020-02-17 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | 0.9% SODIUM CHLORIDE |
| Generic Name | CONTAINER, I.V. |
| Product Code | KPE |
| Date Received | 2020-03-12 |
| Model Number | 2B1324 |
| Lot Number | 323949 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |