Additional information was provided in medwatch form (b)(4), which stated that the devices in question was frequently breaking, requiring new set-up and replacement during infusions.Quest launched an investigation into this complaint.During the investigation, production records were reviewed for all lots of devices that were provided to (b)(6) hospital of (b)(6).Review of these records revealed no apparent production deficiencies related to weak bond strength or breakage.In addition to production record review, quest also performed failure analysis on complaint sample product codes that were received from (b)(4), as well as those retained by quest.Results from testing were unable to replicate the complaint condition of weak weld/breakage.Quest will continue to investigate and monitor trends for this complaint condition.
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