POWERPORT MRI ISP, 8 FR GROSHONG Adverse Event — Injury (MDR 3006260740-2020-01461)
POWERPORT MRI ISP, 8 FR GROSHONG Adverse Event — Injury (MDR 3006260740-2020-01461) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERPORT MRI ISP, 8 FR GROSHONG; Generic name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR; Manufacturer: BARD ACCESS SYSTEMS.
| Device | POWERPORT MRI ISP, 8 FR GROSHONG |
|---|---|
| Generic name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Manufacturer | BARD ACCESS SYSTEMS |
| Report number | 3006260740-2020-01461 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER, HEALTH PROFESSIONAL, |
| Narrative | MANUFACTURING REVIEW: A LOT HISTORY REVIEW WAS CONDUCTED AND IT WAS DETERMINED THAT A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED. INVESTIGATION SUMMARY: A SAMPLE EVALUATION COULD NOT BE PERFORMED AS THE SAMPLES WERE NOT RETURNED THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED BROKEN CATHETER ISSUE DUE TO THE FACT THAT NO SAMPLE WAS RETURNED FOR EVALUATION. ALTHOUGH A DEFINITIV |
| Source | openFDA MAUDE (device adverse events) |
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