Catalog Number 383557 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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It was reported that bd nexiva sp with maxzero tubing detached from the catheter adapter.The following information was provided by the initial reporter: the extension set came off right at the wings of nexiva.
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Manufacturer Narrative
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Investigation results: the complaint that the extension tubing separated from the catheter adapter was confirmed and the cause appeared to be manufacturing related.Two 20g nexiva catheters were returned for investigation.One unit was received in sealed packaging and exhibited no damage or defects.The adhesive was found to be placed in the correct location.The unit that was received in open packaging exhibited misplaced adhesive, which likely allowed the extension tubing to separate from the catheter adapter with minimal stress.The appropriate manufacturing personnel were notified of this complaint.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the defect of ¿separation adapter from tubing¿ was confirmed.Probable root cause: manufacturing.
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Event Description
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No additional information.
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Search Alerts/Recalls
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