BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 7N8378 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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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 address: (b)(6).G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial 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 an one-link non-dehp standard bore catheter extension set leaked.The device disconnected from a catheter resulting in spillage of saline solution.This occurred prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H4: the lot was manufactured between april 04, 2023 - april 05, 2023.H10: 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 received for evaluation; 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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