PORT ACCESS NEEDLE Adverse Event — Malfunction (MDR 10000337)
PORT ACCESS NEEDLE Adverse Event — Malfunction (MDR 10000337) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PORT ACCESS NEEDLE; Generic name: SET, ADMINISTRATION, INTRAVASCULAR; Manufacturer: BARD ACCESS SYSTEMS, INC..
| Device | PORT ACCESS NEEDLE |
|---|---|
| Generic name | SET, ADMINISTRATION, INTRAVASCULAR |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Report number | 10000337 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | PATIENT HAD PORT TUBING BREAK AGAIN ~24 HRS AFTER BEING ADMITTED. THIS TIME CHEMO WAS INFUSING. PARENTS NOTICED A DROP OF METHOTREXATE CHEMO AND NOTIFIED A NURSE. NURSE STOPPED CHEMO. ACCORDING TO NURSES, TUBING BROKE ABOVE NEEDLELESS CONNECTOR. I BELIEVE THIS IS THE SAME PLACE IT HAS BROKEN MULTIPLE TIMES IN THE PAST. PATIENT HAD TO BE DE-ACCESSED, RE-ACCESSED, BLOOD CULTURES WERE DRAWN. REMAINDE |
| Source | openFDA MAUDE (device adverse events) |
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