Model Number 8975 |
Device Problem
Misconnection (1399)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2022 |
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.
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Event Description
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It was reported that the bd ultra-fine¿ mini pen needle was unable to attach.The following information was provided by the initial reporter: consumer reported finding a pen needle that would not attach to pen.
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Manufacturer Narrative
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H6: investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
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Event Description
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It was reported that the bd ultra-fine¿ mini pen needle was unable to attach.The following information was provided by the initial reporter: consumer reported finding a pen needle that would not attach to pen.
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Search Alerts/Recalls
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