POWERSOLO 5 FR TRIPLE LUMEN Adverse Event — Malfunction (MDR 10000325)
POWERSOLO 5 FR TRIPLE LUMEN Adverse Event — Malfunction (MDR 10000325) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERSOLO 5 FR TRIPLE LUMEN; Generic name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30; Manufacturer: BARD ACCESS SYSTEMS, INC..
| Device | POWERSOLO 5 FR TRIPLE LUMEN |
|---|---|
| Generic name | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Report number | 10000325 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | WHILE IN THE PROCESS OF INSERTING A PICC, WAS UNABLE TO THREAD GUIDEWIRE INTO THE PERCUTANEOUS NEEDLE. PT HAD TO BE STUCK A SECOND TIME USING ANOTHER IV CATHETER TO ACCESS VEIN. THE MANUFACTURER WAS NOTIFIED OF THIS EVENT. STAFF ATTEMPTED TO RETURN THE DEVICE TO THE MANUFACTURER, BUT WERE ADVISED BY BARD BD TO DISCARD AS THEY ARE NOT TAKING ANY COVID CONTAMINATED PRODUCTS. THERE HAVE BEEN TWO EVEN |
| Source | openFDA MAUDE (device adverse events) |
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