Model Number MPX9103 |
Device Problem
Separation Failure (2547)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
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Event Description
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It was reported that a extension set tubing separated when attached to the patient at the point of connection between the y-site port and the male luer.It was still inserted into the patient¿s vein.
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Event Description
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It was reported that an extension set tubing separated when attached to the patient, at the point of connection between the y-site port and the male luer.It was still inserted in the patient¿s vein.Although requested, there has been no further patient or event information made available to date.
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Manufacturer Narrative
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Correction; h.6.(patient code).The customer complaint of maxguard extension set tubing broken was confirmed.A photo provided by the customer shows that the non-dhep tubing was separated from the outlet port.Previous investigations have concluded that the root cause of tubing separation issues complaints have concluded to be due to insufficient solvent being applied at the affected engagement due to equipment and/ or operator error.No product will be returned per customer.
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Search Alerts/Recalls
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