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 Problems
Material Twisted/Bent (2981); Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that during removal the safestep huber needle set from the port body, the needle was found to be bent and the safety mechanism was not activated.It is unknown when the needle bend happened.There was no reported patient injury.
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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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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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.Based on a review of this information, the following was concluded: the complaint of bent needle was confirmed and the cause was determined to be use related.The product returned for evaluation was a 22g safestep infusion set.The returned product sample was evaluated and the needle was observed to be bent at two locations, near the needle base and halfway up the needle.The following observations were noted during the sample evaluation: ¿ usage residue was seen on the sample which proved that the product had experienced at least some use.¿ one of the bends in the needle had occurred away from the needle base which can be caused by device manipulation during/following port access.¿ the tip of the needle bevel appeared unremarkable.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass the bent region of the needle.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.
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Event Description
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It was reported that during removal the safestep huber needle set from the port body, the needle was found to be bent and the safety mechanism was not activated.It is unknown when the needle bend happened.There was no reported patient injury.
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Search Alerts/Recalls
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