BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 0652034 |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported by the facility that the pressure was limited coming from two needles, stating it measured at only 250 psi.Facility had to use a new port access needle to finish procedure.This report addresses needle two.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of limited pressure is inconclusive due to unknown clinical conditions.Two 20 ga x 0.75 in powerloc infusion sets were returned for investigation.The safety mechanisms were returned fully activated.The samples were flushed with water using a 12 ml syringe and no apparent resistance was felt.A guidewire was passed through the needle and no obstructions were observed.Based on the description of the reported event, possible contributing factors include partial occlusion within the port and equipment used.As no resistance was observed during infusion and the flow path appeared to be clear of obstructions, the complaint is inconclusive due to unknown clinical conditions.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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It was reported by the facility that the pressure was limited coming from two needles, stating it measured at only 250 psi.Facility had to use a new port access needle to finish procedure.This report addresses needle two.
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