C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Infiltration into Tissue (1931)
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Event Date 05/29/2023 |
Event Type
malfunction
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Event Description
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It was reported by the customer, "having issues with the powerglides at the tip near the pink to green hub having holes in them.Once we flush it, the site appears infiltrated but it's just because there's a hole in the catheter and so any meds sit in the subq tissue.It has happened at least 3 times." while pushing fluid through the catheter, there is a stream of fluid coming out of the side of the catheter, where a hole appears to be.This report addresses the second occurrence.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported by the customer, "having issues with the powerglides at the tip near the pink to green hub having holes in them.Once we flush it, the site appears infiltrated but it's just because there's a hole in the catheter and so any meds sit in the subq tissue." while pushing fluid through the catheter, there is a stream of fluid coming out of the side of the catheter, where a hole appears to be.Additional information received 06/12/2023: in two instances, they were flushed with a bit of the tip out and when flushed, it sprayed saline in the air.No harm occurred but we had to pull the line and start another.This report addresses the second spraying occurrence.
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