Catalog Number 383318 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 the contaminated bd saf-t-intima¿ iv catheter safety system needle "slid past the safety device" when it was pulled back and was left exposed.
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Event Description
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It was reported that the contaminated bd saf-t-intima¿ iv catheter safety system needle "slid past the safety device" when it was pulled back and was left exposed.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 8025693.Our records show that this is the only instance of this issue 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.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.Based on investigation results, the root cause was not identified because the customer did not provide the sufficient information (sample or picture) which is essential to perform a better investigation.
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Search Alerts/Recalls
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