Catalog Number 392623 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd iag bc pro wing blu 22ga x 1.0in leaked blood.The following information was provided by the initial reporter: rn placed a 22g iaug blood control iv and it spilled blood everywhere.
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Manufacturer Narrative
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No photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number (b)(4) and lot number 3207476.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Based on the available information, an exact cause for this incident could not be identified.
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Event Description
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No additional information.
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Search Alerts/Recalls
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