MINICAP TRANSFER SET Adverse Event — Malfunction (MDR 1416980-2020-02386)
MINICAP TRANSFER SET Adverse Event — Malfunction (MDR 1416980-2020-02386) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MINICAP TRANSFER SET; Generic name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE; Manufacturer: BAXTER HEALTHCARE CORPORATION.
| Device | MINICAP TRANSFER SET |
|---|---|
| Generic name | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Report number | 1416980-2020-02386 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, CONSUM |
| Narrative | ADDITIONAL INFORMATION: H3, H6. H10: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A LOOSE BLUE PULL RING CAP INSIDE AN OPENED POUCH. THE REPORTED CONDITION WAS VERIFIED. THE LOOSE CAP IS THE CAUSE OF THE REPORTED PROBLEM. THE CAUSE OF THE LOOSE CAP COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS |
| Source | openFDA MAUDE (device adverse events) |
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