Catalog Number AMC9607C |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2024 |
Event Type
malfunction
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Event Description
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It was reported the blue clamp of two (2) light sensitive drug sets were found to be in an inverted position.The inverted clamp did not allow the equipment to attach correctly to the infusion bag.This was observed before patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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E1: initial reporter last name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The actual device was not available; however, three (3) retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.It was confirmed that the blue slide clamp was assembled in a correct position (notch near to roller clamp).The reported condition was not 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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Search Alerts/Recalls
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