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
Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
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 is pending evaluation.Results are expected soon.
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Event Description
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It was reported that the safety mechanism did not work when the needle was removed.There was no reported patient injury.No other information was provided.
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Event Description
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It was reported that the safety mechanism did not work when the needle was removed.There was no reported patient injury.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 difficulty activating a safety mechanism is confirmed; however, the exact cause is unknown.One video of a 22 g safestep infusion set was returned for evaluation.An initial visual observation of the video showed an attempt to activate the safety mechanism; however, it was observed that the safety mechanism was unable to completely cover the needle tip.Some use residue was observed.No damage to the device could be discerned from the provided video.There were no distinguishing features in the returned video of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
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