Since (b)(6) 2020, multiple (10) patient safety alerts have been reported by multiple clinical units, involving concerns with medline silicone urinary catheters.Summary of events include: on (b)(6): positive catheter associated urinary tract infection (cauti), (b)(6): leaking around catheter insertion site, (b)(6): catheter plugged, not draining, unable to flush; (b)(6): leaking from flush port, (b)(6): leaking at insertion site, balloon inflated correctly, (b)(6): unable to inflate properly, attempted removal, balloon unable to deflate, imaging revealed balloon in urethra.Balloon tubing had to be cut and balloon deflated through scrotum, (b)(6): insertion with no urine output and difficulty on insertion.Inserted latex catheter with no difficulty and urine output occurred; (b)(6): leaking at insertion site, (b)(6): leaking at insertion site, (b)(6), leaking at insertion site.Fda safety report id# (b)(4).
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