ST PAUL DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number 21-2733-24 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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One unit was received for evaluation; the returned unit was received decontaminated without its original packaging.The unit was tested for occlusion by introducing water with a syringe and found occlusion between the tube and luer.The failure mode reported is confirmed.As part of the standard process, production personnel perform a 100% visual inspection on the base for excess solvent and delamination.The root cause is excess solvent in the component bonding operation.Awareness notification was made to production personnel for the occlusion failure mode.Device history record (dhr) review relevant to the lot reported found no discrepancies or anomalies during manufacturing.This remediation mdr was generated under protocol (b)(4)., as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that the line would not prime past the top of the line/needle as if there is a blockage.No patient injury was reported.
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Search Alerts/Recalls
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