QUICK-SET® PARADIGM® Adverse Event — Malfunction (MDR 3003442380-2020-00255)
QUICK-SET® PARADIGM® Adverse Event — Malfunction (MDR 3003442380-2020-00255) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: QUICK-SET® PARADIGM®; Generic name: QUICK-SET 60/9 PCC; Report number: 3003442380-2020-00255.
| Device | QUICK-SET® PARADIGM® |
|---|---|
| Generic name | QUICK-SET 60/9 PCC |
| Report number | 3003442380-2020-00255 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR |
| Narrative | UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S WIFE REPORTED THAT HER HUSBAND'S INFUSION SET'S TUBING HAD DISCONNECTED AT THE SITE CONNECTOR, WHILE DOING NOTHING. THE SITE LOCATION WAS HIS ABDOMEN AND THE PUMP WAS LOCATED IN HIS POCKET. THE INFUSION HAD BEEN USED FOR ONE DAY. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOS |
| Source | openFDA MAUDE (device adverse events) |
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