JOEY 1000ML SAFETY SCREW SPIKE Adverse Event — Malfunction (MDR 1282497-2020-09037)
JOEY 1000ML SAFETY SCREW SPIKE Adverse Event — Malfunction (MDR 1282497-2020-09037) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: JOEY 1000ML SAFETY SCREW SPIKE; Generic name: PUMP, INFUSION, ENTERAL; Manufacturer: COVIDIEN.
| Device | JOEY 1000ML SAFETY SCREW SPIKE |
|---|---|
| Generic name | PUMP, INFUSION, ENTERAL |
| Manufacturer | COVIDIEN |
| Report number | 1282497-2020-09037 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE I |
| Source | openFDA MAUDE (device adverse events) |
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