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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..

DevicePORT ACCESS NEEDLE
Generic nameSET, ADMINISTRATION, INTRAVASCULAR
ManufacturerBARD ACCESS SYSTEMS, INC.
Report number10000337
Event typeMalfunction
Product problemY
Date received2020-04-27
NarrativePATIENT 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
SourceopenFDA MAUDE (device adverse events)

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