Model Number 30893-07 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Pain (1994)
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Event Date 10/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Event Description
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It was reported that leaking is observed in the tubing to male luer engagement towards the side where epidural catheter's hub is connected.The customer pointed out the site of leak in the photo provided.There was no patient injury, however the patient was in pain due to not receiving the medication as it leaked out of the tubing.
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Event Description
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It was reported that leaking was observed at the male luer engagement, the side where epidural catheter's hub is connected.There was no patient injury, however; the patient was in pain due to not receiving the medication, as it leaked out of the tubing.
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Manufacturer Narrative
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The customer¿s report that leaking was observed at the male luer engagement was confirmed.The sets were visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears in the tubing and its components.A residual clear, colorless liquid was present within the sets.Visual inspection of the set noted no damage or any anomalies.Examination under magnification revealed some solvent channels at the exterior tubing and interior male luer surfaces that seemed more evident along the area of the yellow stripe of the microbore tubing.Functional and pressure testing confirmed small droplets leaking at the engagement between the tubing and the inlet port of the male luer on each set.The root cause is improper solvent application due to inadequate maintenance of the solvent dispenser and an improper holding time.This creates an inadequate interaction at the affected engagement that can lead to leaks after sterilization.
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Manufacturer Narrative
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Additional medwatch information provided.
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Event Description
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Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the tubing leaks from the distal end where the port is connected.This is a recurring problem across multiple lots.The problem cannot be detected until the line is in the patient and m use.Discussed with staff m central distribution for this facility system.They are seeing this problem at multiple facilities and in multiple lots.The manufacturer has been notified and product has been returned.Multiple reports are being sent to the manufacturer about this problem.".
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Search Alerts/Recalls
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