BAXTER HEALTHCARE - MOUNTAIN HOME UV FLASH TRANSFER SETS; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number T5C4326 |
Device Problems
Device Slipped (1584); Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/10/2014 |
Event Type
malfunction
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Event Description
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It was reported that a uv flash transfer set would not connect properly with a titanium adapter.It became loose after being connected to the titanium adapter.There was no patient injury, medical intervention or adverse event associated with this event.No additional information is available.
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Manufacturer Narrative
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(b)(4).A request for the return of the device has been made.If additional relevant information is obtained, then a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).A review of all batch record documents was performed for lot number h13i16036 with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition noted.An evaluation of the actual sample was conducted.Visual inspection using a microscope, leak testing, clamp function testing and clear passage testing were performed with no issues noted.The integrity of the seal surface was tested with no leaks noted.The dimensional inspection of the returned transfer set sample found the diameter of the catheter connector/patient connector to be within specifications.The sample was not confirmed for the reported issue and a cause could not be determined as the device was found to be within product specifications.If additional relevant information is obtained, then a follow-up mdr will be submitted.
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Search Alerts/Recalls
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