Catalog Number 385100 |
Device Problem
Particulates (1451)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that bd¿ q-syte had white rubber inside the connector.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 7327639 our records determined that this is the only instance of a occluded device occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that bd¿ q-syte had white rubber inside the connector.
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Search Alerts/Recalls
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