BAXTER HEALTHCARE CORPORATION MINICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4466P |
Device Problem
Fitting Problem (2183)
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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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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 a minicap had a connection issue with a transfer set; further described as "mini cap would not screw onto a transfer set".It was further reported there seemed to be an issue with the threads in the cap; one was disrupted.This was observed during set up for peritoneal dialysis therapy.The transfer set remained in use.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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Additional information: d9, h3, h6, h10.H10: one actual sample was received for evaluation.A visual inspection with the naked eye noted the threads of the sample were damaged.Approximately half of the threads were not properly formed and the wall of the sample showed signs of deformation/damage along its circumference.A functional test was performed in which the sample was paired with a mock transfer set to test the sample¿s threads.The provided sample could not be secured to the given transfer set.The reported condition was verified.The cause of the event was determined to be manufacturing related and the most likely cause was mechanical damage during molding.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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