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 02/17/2024 |
Event Type
malfunction
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Event Description
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It was reported that safety mechanism did not work when removing the needle.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 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 safety mechanism did not work when removing the needle.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 advancing the safety mechanism was confirmed and the cause was determined to be supplier related.The product returned for evaluation was one 22g safestep infusion set.The investigation findings were consistent with misplaced or excess manufacturing adhesive, which bound the safety mechanism to the needle.The following observations were made during the sample evaluation: the safety mechanism was not engaged over the needle tip and was returned positioned at the needle base microscopic examination under uv light assistance revealed a white/clear adhesive-like substance at the interface of the needle shaft and safety mechanism.That material fluoresced under ultraviolet light, which was consistent with the adhesive used to assemble the infusion set.From this, it appeared that adhesive was deposited on the needle shaft during device manufacture.The device is a supplied component and the supplier was notified of the event.
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