Catalog Number SR*FF2225 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Fever (1858); Swelling (2091)
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Event Date 11/30/2017 |
Event Type
Injury
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Manufacturer Narrative
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Patient involved was a canine; implanted date: device was not implanted, explanted date: device was not explanted.No results available since no evaluation performed: based off the actual device unavailable to be evaluated, no failure detected: based off the reserve sample evaluated.The actual sample was not available for investigation.Retention samples were observed and no anomalies were found with the needle tip, and there was no contamination inside the needles.Penetration resistance check was performed.A polyethylene sheet with 50-micron thickness was used for insertion resistance and was measured, with values within manufacturer specification.A review of the manufacturer inspection record of the involved lot number revealed no relevant findings.The corresponding product type has been tested in accordance with iso (b)(4) safety inspection (biological evaluation of medical device).(b)(4).
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Event Description
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The user facility reported vein blow.Follow up communication with the user facility reported the following information: customer said they have been experiencing vein blow which then is causing injection with swelling and fever with the 22x1 surflash catheter.They have been using this product since 2015.They said this has occurred a few times.The customer stated that the longer the product was left in the patient, the more likely this issue was to occur.There was medical intervention as the need to provide care to manage phlebitis.All of the animals (dogs) have recovered.
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Manufacturer Narrative
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This report is being submitted as follow up no.2 to provide a correction to catalog # and lot #.It was initially reported as sr-ff2225 and 170213a.Manufacture date is 08/24/2015-08/25/2017.
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Manufacturer Narrative
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This report is being submitted as follow up no.1.The conclusion in section was inadvertently entered as (b)(4).The correct have been entered.(b)(4) no failure detected, device opereated within specification: based off retention sample, 67: unable to confirm complaint: based off no sample returned.
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Search Alerts/Recalls
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