C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION 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
Pain (1994)
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Event Date 04/14/2023 |
Event Type
malfunction
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Event Description
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Customer states that when they place the powerloc max port access needle they hear a clicking noise like the safety feature engages when the needle is placed.When they go to de-access the needle, the safety mechanism does not engage and the needle will not slide back.They have had to grip the entire base of the needle and pull it out.They claim this way to disengage the needle causes more pain for the patient and has an increase in accidental needle stick risk for the bedside nurse.It was reported this occurred with thirty devices.This report addresses the first device.
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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 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.The complaint of difficulty advancing the safety mechanism was confirmed and the cause was supplier-related.The product returned for evaluation was one 20ga x 0.75¿ powerloc max safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged over the needle tip.The safety fully contained the needle tip.The safety mechanism was reset and then reactivated.Activation of the safety was successful and unremarkable.Microscopic inspection of the safety mechanism revealed clear material adhered to both the needle housing at the needle exit site and on the metal sleeve on the engaged safety mechanism.The material fluoresced under ultraviolet light.The clear, fluorescing material was consistent with the adhesive used to assembly the infusion set and was apparently deposited during device manufacture.The safety mechanism was received activated and appeared to function as intended; however, the presence of adhesive on the needle housing and safety sleeve suggested that resistance would have been initially encountered, as extra effort would be required to overcome the adhesive bond between the sleeve and the housing.The device is a supplied component and the supplier has been notified of this event.H3 other text : evaluation findings are in section h11.
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Event Description
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Customer states that when they place the powerloc max port access needle they hear a clicking noise like the safety feature engages when the needle is placed.When they go to de-access the needle, the safety mechanism does not engage and the needle will not slide back.They have had to grip the entire base of the needle and pull it out.They claim this way to disengage the needle causes more pain for the patient and has an increase in accidental needle stick risk for the bedside nurse.It was reported this occurred with thirty devices.This report addresses the first device.
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Search Alerts/Recalls
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