Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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H.6.Investigation: no samples were returned as of 20 november 2020, therefore the investigation was performed based on the photos provided.Two photos of a (1) loose 0.3ml bd insulin syringe were provided.Consumer reported the hub-needle / shield (orange) assembly was separated from the barrel.The provided photos were reviewed, and it was observed that the syringe exhibited a separated needle hub / shield assembly; no damage to the barrel tip was observed.Unable to perform a dhr review due to an unknown lot number for needle hub separates.Process summary: automatic syringe assembly machine, which feeds 0.3ml, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger / stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Root cause: maintenance dispatch was opened for raised hubs.A couple of plunger heads were stuck in the carrier causing a reduce amount of pressure applied when attaching the needle assembly to the barrel.
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