BARD ACCESS SYSTEMS POWERPORT MRI ISP, 8 FR CHRONOFLEX, SUTURE PLUG, ATTACHABLE, SL; IMPLANTABLE PORT
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Model Number 1808060 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The lot number was provided for the malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 1808060 implantable port allegedly experienced use of device issues.This information was received from one source.Of the one use of device issues, one involved a patient with no patient consequences.The patient was a (b)(6) year old female and weighed (b)(6) kgs.
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Search Alerts/Recalls
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