Catalog Number 11448964 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the sec set no ports w/hanger dehp free experienced component separation.The following information was provided by the initial reporter: material no: 11448964.Batch no: 20083415.Nurse grabbed a secondary set and noticed the tubing was apart.She brought it to me and i called iv team educator.Bedside rn was preparing for a secondary infusion.When tubing was open tubing was not connected to bottom of drip chamber.Appears to be no bonding between pieces.
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Event Description
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It was reported that the sec set no ports w/hanger dehp free experienced component separation.The following information was provided by the initial reporter: material no: 11448964, batch no: 20083415.Nurse grabbed a secondary set and noticed the tubing was apart.She brought it to me and i called iv team educator.Bedside rn was preparing for a secondary infusion.When tubing was open tubing was not connected to bottom of drip chamber.Appears to be no bonding between pieces.
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Manufacturer Narrative
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H6: investigation summary.Customer reported tubing disconnected and returned the affected sample.The sample was clearly separated at the outlet of the drip chamber and the complaint is verified.Visual inspection under the microscope determined the root cause to be insufficient solvent.Dimensional analysis found the tubing to be within tolerance.No other failure modes were observed.A device history record review for model 11448964 lot number 20083416 was performed.H3 other text : see h.10.
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Search Alerts/Recalls
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