BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 7N8300 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that the packaging (print side) of an unspecified quantity of one-link non-dehp microbore catheter extension sets were damaged; further described as "plastic breaking down and cracking".This was observed prior to use.The packaging was brittle and fell apart when touched.The sets were stored in plastic bins in a temperature-controlled area without any extreme temperatures.There was no patient involvement.No additional information is available.
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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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Manufacturer Narrative
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H10: the actual devices were not available; however, a photograph of samples was provided for evaluation.Visual inspection of the photograph identified the top web (lidding material) of the packaging was damaged/cracked.The reported condition was verified.The cause of damage could not be determined; however, a probable cause was prolonged exposure to inadequate storage conditions.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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