C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G 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
Infiltration into Tissue (1931)
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Event Date 04/11/2023 |
Event Type
malfunction
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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 manufacturer has received the sample and will evaluate.Results are expected soon.
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Event Description
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It was reported that the device was accessed to the port body at 5 am.It was confirmed that blood return could be confirmed and the needle was correctly accessed to the port body.Around 3:00 pm, it was found that an anticancer agent leaked subcutaneously.The health injury to the patient was unknown.
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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 complaint of a leaking infusion set is unconfirmed because the problem could not be reproduced.One 22 ga x 0.75 in safestep infusion set was retuned for evaluation.An initial visual observation showed use residues throughout the returned device, and nothing remarkable was observed during a gross visual observation.A functional test of infusing water into the infusion set using a 12 ml syringe proved the device to be patent to infusion and aspiration.Pressurization of the device did not reveal any leaks throughout the safestep.The complaint of a leaking infusion set was unconfirmed as pressurization of the device could not recreate or locate a leak.Possible causes of this perceived failure may include the needle not being inserted entirely into the port septum, causing the infusate to appear to leak near the insertion site.
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Event Description
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It was reported that the device was accessed to the port body at 5 am.It was confirmed that blood return could be confirmed and the needle was correctly accessed to the port body.Around 3:00 pm, it was found that an anticancer agent leaked subcutaneously.The health injury to the patient was unknown.
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