Catalog Number 2C2123K |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the fill port cap of an extra large volume intermate was loose.This issue was further described as, ¿top cap was loose on device¿.This issue was discovered before patient use.There was no patient involvement.No additional information was available.
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph shows the fill port cap separated from the fill port.The reported condition was verified.The cause of the condition could not be verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H11: the device was received for evaluation.A visual inspection was performed, and the fill port cap was separated from the device.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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