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POWERPICC SOLO2 HF CATHETER Adverse Event — Malfunction (MDR 10000318)

POWERPICC SOLO2 HF CATHETER Adverse Event — Malfunction (MDR 10000318) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERPICC SOLO2 HF CATHETER; Generic name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30; Manufacturer: BARD ACCESS SYSTEMS, INC..

DevicePOWERPICC SOLO2 HF CATHETER
Generic nameCATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30
ManufacturerBARD ACCESS SYSTEMS, INC.
Report number10000318
Event typeMalfunction
Product problemY
Date received2020-04-27
NarrativeWHILE IN THE PROCESS OF PLACING A TRIPLE LUMEN PICC, THE GUIDEWIRE DID NOT THREAD THROUGH THE PERCUTANEOUS NEEDLE SUPPLIED IN THE KIT. PT NEEDED TO BE STUCK A SECOND TIME TO ACCESS THE VEIN USING ANOTHER IV 20G B-BRAUN ALSO SUPPLIED IN THE KIT. 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 N
SourceopenFDA MAUDE (device adverse events)

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