Catalog Number 383323 |
Device Problem
Hole In Material (1293)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that a hole was found in the extension of a bd saf-t-intima¿ iv catheter safety system.There was no report of exposure, injury or medical intervention.
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Manufacturer Narrative
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No samples displaying the condition reported are available for examination.We were unable to fully investigate this occurrence.A review of the device history records revealed no irregularities during the manufacture of reported lot number 7115938.We could not confirm or associate the issue to manufacturing process, without defective sample or photo for evaluation.
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Search Alerts/Recalls
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