Model Number 320550 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) there was difficulty priming.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported when completing a flow check finding the pen needle to clog.Most all in this box.
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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 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.H3 other text : see h10.
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Event Description
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It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) there was difficulty priming.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported when completing a flow check finding the pen needle to clog.Most all in this box.
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Search Alerts/Recalls
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