Model Number N/A |
Device Problem
Defective Component (2292)
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Patient Problem
Injury (2348)
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Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redx2355 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2355) have been reported from the same facility.
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Event Description
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It was reported that the accucath guide wire is bending and coming out the side of the device and is not allowing full retract of the accucath needle.This issue is causing patient vein damage and safety issues for staff and patients.It was stated this occurred twice with lot redx2355.This report addresses the second device.
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Event Description
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It was reported that the accucath guide wire is bending and coming out the side of the device and is not allowing full retract of the accucath needle.This issue is causing patient vein damage and safety issues for staff and patients.It was stated this occurred twice with lot redx2355.This report addresses the second 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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx2355 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2355) have been reported from the same facility.
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Search Alerts/Recalls
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