BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93811 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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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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E1: initial reporter facility name: (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 there was particulate matter (pm) contamination on the tubing of a repeater pump tube set.The pm was further described as, "a black line was immediately noticed in the hose, which when moved with a finger, it turned out to be a hair".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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The device was received for evaluation.A visual inspection was performed, and a loose hair inside the opened primary packaging was observed.The reported condition was verified.The cause of the reported condition could not be determined; however, the possible cause was a manufacturing issue.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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