Catalog Number 381123 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).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 angiocath bl 22ga x 1.0in had no label.This occurred on 50 occasions.The following information was provided by the initial reporter: the 50 small boxes in the operating room have no green inspection label.
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Manufacturer Narrative
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Correction: the initial mdr was completed in error with the incorrect reportability.This complaint is not mdr reportable.The green label is not a us fda label requirement, and failure to include an inspection label would not cause or contribute a death or serious injury.The initial mdr is void.
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Event Description
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It was reported that angiocath bl 22ga x 1.0in had no label.This occurred on 50 occasions.The following information was provided by the initial reporter: the 50 small boxes in the operating room have no green inspection label.
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Search Alerts/Recalls
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