BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Catalog Number H93811 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
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 the tip (spike) of four (4) sterile repeater pump tube sets broke off.This was observed during use with a non-baxter bag.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The lot was manufactured between february 3, 2023 ¿ february 4, 2023.The actual devices were not available; however, photographs of a sample were provided for evaluation.Visual inspection was performed on the photographs which identified the spike tip was bent.The reported condition was verified as a bent tip.The cause of the bent tip 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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