KANG EPUMP 500ML PUMP SET-INTL Adverse Event — Malfunction (MDR 1282497-2020-09042)
KANG EPUMP 500ML PUMP SET-INTL Adverse Event — Malfunction (MDR 1282497-2020-09042) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: KANG EPUMP 500ML PUMP SET-INTL; Generic name: PUMP, INFUSION, ENTERAL; Manufacturer: COVIDIEN.
| Device | KANG EPUMP 500ML PUMP SET-INTL |
|---|---|
| Generic name | PUMP, INFUSION, ENTERAL |
| Manufacturer | COVIDIEN |
| Report number | 1282497-2020-09042 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | EVALUATION SUMMARY: THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE REPORTED LOT NUMBER SHOWS EVIDENCE THAT THE PRODUCT WAS RELEASED ACCORDING TO ALL ESTABLISHED PROCEDURES AND QUALITY DOCUMENTATION. A SAMPLE WAS RECEIVED AT THE MANUFACTURING PLANT FOR EVALUATION. A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED, AND LEAKING WAS FOUND BETWEEN THE BAG AND THE LINE. THE EXACT ROOT CAUSE COULD NOT BE D |
| Source | openFDA MAUDE (device adverse events) |
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