Catalog Number 5346 |
Device Problems
Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been returned to the manufacturer.However, the investigation of said device is still in progress at the time of this report.This report will be updated at the conclusion of the device evaluation.
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Event Description
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Customer complaint alleges "when this product connects reservoir valve assembly and intake valve housing assembly, the connected part is loose and easily dislodged." alleged defect reported as prior to patient use, during inspection/ functional testing.No report of patient harm.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.The dimensions of the fitting port were measured and were found to be within specification.The reservoir valve was completely assembled to the intake valve.The reservoir valve matched firmly with the intake valve.The sample was then functionally tested.No issues were found with the reservoir valve.Based on the investigation performed, the reported complaint of "loose connection with valve and housing" could not be confirmed.There were no issues found with the returned sample.
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Event Description
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Customer complaint alleges "when this product connects reservoir valve assembly and intake valve housing assembly, the connected part is loose and easily dislodged." alleged defect reported as prior to patient use, during inspection/ functional testing.No report of patient harm.
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Search Alerts/Recalls
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