C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Activation Problem (4042)
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Patient Problem
Discomfort (2330)
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Event Date 10/30/2023 |
Event Type
malfunction
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Event Description
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It was reported by the customer that while de-accessing a patient's port, the base of the port got stuck halfway through the shaft of the needle.This resulted in not being able to use the safety mechanism, which means there was a potential for the team member needle stick and also patient discomfort due to difficult de-accessing the port.
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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.
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Event Description
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It was reported by the customer that while de-accessing a patient's port, the base of the port got stuck halfway through the shaft of the needle.This resulted in not being able to use the safety mechanism, which means there was a potential for the team member needle stick and also patient discomfort due to difficult de-accessing the port.
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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 is confirmed and was determined to be related to the supplier.One 22 ga x 1.0 in.Powerloc max infusion set without a y-site was returned for evaluation.An initial visual observation showed use residues along the returned infusion set.The safety mechanism was advanced over the needle tip upon the return of the device.A microscopic observation revealed a ring of excessive adhesive along the metal cannula just proximal of the safety mechanism.Excessive adhesive was also observed where the needle and the needle housing interface.Using a uv light, the ring of adhesive was visible around the metal cannula just proximal of the safety mechanism.Because excessive adhesive was found along the safety mechanism, the complaint of difficulty advancing the safety mechanism is confirmed and was determined to be supplier related.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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