C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
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 during infusion via female luer connector, the leak was found on y site.No other information was provided.
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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 leak in the infusion set was confirmed and the damage appeared to be supplier related.One 22g x 3/4" w/y-site safestep infusion set was provided for investigation.A functional test revealed that fluid would leak out of the infusion set through the y-site during aspiration.A continuous slow leak of fluid was observed when the infusion set was pressurized.The affected valves were cut open and the valve stem was removed, which revealed flow lines in the sealing surface of the valve stem and pitting in other areas of the valve stem.The damage to the sealing surface of the valve stem was located in an area that was inaccessible to the user.The uneven areas of the valve stem sealing surface most likely allowed air to bypass the valve during aspiration.Bd is working closely with the supplier to prevent recurrence of the reported event.
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Event Description
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It was reported that during infusion via female luer connector, the leak was found on y site.No other information was provided.
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Search Alerts/Recalls
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