Model Number 306424 |
Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that two 5 ml bd posiflush¿ heparin lock flush syringe, 500 usp units/5ml does not have the manufacturer label.The following information was provided by the initial reporter: patient received a sealed box of heparin 100u/ml flushes wherein 2 flushes had not manufacturer label.
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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.The initial reporter also notified the fda on 05 may, 2022.Medwatch report # mw5109587.
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Manufacturer Narrative
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This complaint has been determined to be a duplicate of mfr report# 1911916-2022-00276.The original submission, 1911916-2022-00311 can therefore be disregarded.
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Event Description
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It was reported that two 5 ml bd posiflush¿ heparin lock flush syringe, 500 usp units/5ml does not have the manufacturer label.The following information was provided by the initial reporter: patient received a sealed box of heparin 100u/ml flushes wherein 2 flushes had not manufacturer label.
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Search Alerts/Recalls
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