Catalog Number L5C4531 |
Device Problems
Hole In Material (1293); Misassembled (1398)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 three (3) homechoice cassettes were damaged.This issue was observed during set up and the patient was not connected.The patient stated the patient line luer was not connected to the tube correctly; it was bent at an odd angle.The patient stated as a result, the tilted luer had punctured a hole in the tubing.The patient stated they had not seen anything unusual with the packaging; no sharp objects were used to open the supplies.The damage was not visible from the over pouch.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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