Catalog Number 329705 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Erythema (1840); Hyperglycemia (1905)
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Event Date 12/06/2022 |
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.Device expiration date: unknown.Device manufacture date: unknown.
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Event Description
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It was reported that the bd autoshield¿ duo pen needle leaked the drug solution.The following information was provided by the initial reporter, translated from japanese to english: the drug solution leaked.
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Manufacturer Narrative
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H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
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Event Description
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It was reported that the bd autoshield¿ duo pen needle leaked the drug solution.The following information was provided by the initial reporter, translated from japanese to english: the drug solution leaked.
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Search Alerts/Recalls
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