C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Pain (1994)
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Event Date 02/12/2023 |
Event Type
malfunction
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Event Description
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It was reported via medwatch "soft tubing just before the proximal port just before where soft tubing connects to hard plastic, it was found to have crack noted during infusion.This opened up central line to infection and necessitated needle removal and reinsertion.Painful in child.".
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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.
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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 via medwatch "soft tubing just before the proximal port just before where soft tubing connects to hard plastic, it was found to have crack noted during infusion.This opened up central line to infection and necessitated needle removal and reinsertion.Painful in child." additional information received 07/04/2023: patient being treated for acute myelocytic leukemia no urgent/life threatening medical situation.Ivf and intermittent antibiotics, blood leakage and medication.Transparent dressing/tape catheter securement was utilized.No patient harm, injury, or negative outcome.
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