Model Number 320550 |
Device Problem
Leak/Splash (1354)
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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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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 insulin squirted out of the side of the bd nano¿ 2nd gen pen needle hub during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "consumer reported found 2 pen needles insulin squirted out the side of the hub".
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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 insulin squirted out of the side of the bd nano¿ 2nd gen pen needle hub during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "consumer reported found 2 pen needles insulin squirted out the side of the hub".
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Search Alerts/Recalls
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