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
Device Dislodged or Dislocated (2923)
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Patient Problems
Infiltration into Tissue (1931); Insufficient Information (4580)
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Event Date 10/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported that after the device was accessed to the port body, the next time the device was checked, the needle was stuck under the skin.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.
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Event Description
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It was reported that after the device was accessed to the port body, the next time the device was checked, the needle was stuck under the skin.The health injury to the patient was unknown.Additional information received 11/07/2022: was there medication infusing when the needle was found dislodged? high calorie infusion.Was there any harm to the patient? although the medicinal solution was accumulated under the skin, there were no sequelae afterward.Was the needle removed? was a new needle placed? i replaced it with a new safe step and used it.Was the dressing intact? replaced with new dressing.What type of securement device was used? i was using 3m/tegaderm.
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