Model Number 2420-0500 |
Device Problems
Contamination (1120); Material Separation (1562)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 08/02/2019 |
Event Type
Injury
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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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Customer advocacy received a copy of the customer's medwatch report which states, "the iv tubing was connected to a patient infusing oxytocin.During delivery the tubing disconnected from the connection port.The actual disconnection happened where the tubing should remain intact in the lowest portion of the connection port.This caused the site and iv tubing to become contaminated resulting in the patient requiring a new iv site and new tubing and meds to be started on a patient during delivery.Fda safety report id# (b)(4).".
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Manufacturer Narrative
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After file review, in the absence of clarification from the customer, file updated to serious injury based on the report from the medwatch received.
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Event Description
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Customer advocacy received a copy of the customer's medwatch report which states, "the iv tubing was connected to a patient infusing oxytocin.During delivery the tubing disconnected from the connection port.The actual disconnection happened where the tubing should remain intact in the lowest portion of the connection port.This caused the site and iv tubing to become contaminated resulting in the patient requiring a new iv site and new tubing and meds to be started on a patient during delivery.Fda safety report id#(b)(4)." although requested, there is no additional patient or event information available.
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Manufacturer Narrative
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The customer¿s report that the tubing disconnected from the connection port was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear fluid was observed throughout the set.No anomalies or damages were observed with the set.Functional testing did not observe any disconnections from the female/male ports or any issues with the administration set.Visual inspection and pressure testing also found no anomalies with the returned set.The mating components that were in use at the time of the customer event were not returned for investigation.The root cause that the tubing disconnected from the connection port was not identified.
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Event Description
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Customer advocacy received a copy of the customer's medwatch report which states, "the iv tubing was connected to a patient infusing oxytocin.During delivery the tubing disconnected from the connection port.The actual disconnection happened where the tubing should remain intact in the lowest portion of the connection port.This caused the site and iv tubing to become contaminated resulting in the patient requiring a new iv site and new tubing and meds to be started on a patient during delivery.Fda safety report id#(b)(4)." although requested, there is no additional patient or event information available.
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Search Alerts/Recalls
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