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Model Number 5833730 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be 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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 09/2019).
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Event Description
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It was reported that upon unpacking the dialysis catheter kit, foreign material was allegedly found inside the introducer needle, which rendered the device unusable.Reportedly, another device was used to complete the procedure.There was no patient contact.
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Search Alerts/Recalls
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