Model Number 30212E |
Device Problems
Fluid/Blood Leak (1250); Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
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Event Description
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The customer reported that the tubing of an infusion of d5w.5 ns plus 20meq kcl was noted to be kinked in several places while connected to a patient's central line.While attempting to unkink the tubing, it was noted that the extension tubing was leaking at the connection point to another set.There was no patient harm.
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Manufacturer Narrative
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Correction: omit pri tubing from concomitant medical products on initial report.The customer¿s report of ¿leaked at connection to another set¿ was confirmed.Visual inspection observed a crack in the female luer wall on the opposite end of the injection gate on both sets.No tool marks or signs of over torque were observed.Functional testing was performed; the set leaked from the crack in the female luer.The cause of the leak was a cracked female luer.The root cause of this failure is the result of multiple contributing factors such as material regrind, gate location and the effect of chemical agents on mechanical connections of the luer.
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Event Description
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The customer reported that the during an infusion of d5w and 0.45% ns plus 20meq kcl into the patient¿s central line, the tubing was found kinked in several places.After straightening out the tubing, a leak was detected at the extension set connection point.The extension tubing was replaced without incident.There was no report of patient harm.
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Search Alerts/Recalls
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