Catalog Number 326638 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
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 ultra-fine¿ ii 3/10ml insulin syringe drug solution could not be drawn.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the drug solution could not be drawn with the product.
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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.Due to the batch being unknown, no dhr review can be completed.H3 other text : see h10.
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Event Description
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It was reported that the bd ultra-fine¿ ii 3/10ml insulin syringe drug solution could not be drawn.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the drug solution could not be drawn with the product.
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Search Alerts/Recalls
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