C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G 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 10/04/2023 |
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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Event Description
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It was reported by customer that they had a report of a huber needle safety that was difficulty to engage.No other information was provided.
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Event Description
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It was reported by customer that they had a report of a huber needle safety that was difficulty to engage.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 engaging the safety of an infusion set is confirmed and was determined to be supplier related.One 20 ga x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation showed little use residues throughout the returned infusion set.The safety mechanism was observed to be engaged over the needle.A functional test of deactivating the safety and reactivation of the needle safety mechanism revealed activation was smooth.A microscopic observation revealed adhesive around the metal sleeve that slides just above the needle safety mechanism.When excessive adhesive is used during the manufacturing process of gluing the needle housing together, it can flow onto the metal sleeve above the safety mechanism causing it to stick to the needle housing.Because a ring of adhesive was observed along the metal sleeve above the safety mechanism, the complaint of difficulty engaging the safety of an infusion set it confirmed.This complaint will be recorded for future trending and monitoring purposes.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the supplier to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h11.
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