Model Number 320550 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that 2 bd nano¿ 2nd gen pen needles had no tear drop label attached prior to use.The following information was provided by the initial reporter: "consumer reported "tear drop labels" is not on pen needle prior to use 2 pen needles affected".
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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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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 that 2 bd nano¿ 2nd gen pen needles had no tear drop label attached prior to use.The following information was provided by the initial reporter: "consumer reported "tear drop labels" is not on pen needle prior to use 2 pen needles affected".
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Search Alerts/Recalls
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