Catalog Number 2C6700 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the tubing detached from the filter chamber of an interlink straight type blood set.This was observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H11: the actual device was not available; however, three (3) photographs of the sample were provided for evaluation.A visual inspection of the photographs was performed which identified a separation between the tubing and the blood filter chamber.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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